Vehicle comprising extracorporeal blood treatment machine

ABSTRACT

A vehicle is provided that includes a vehicle navigation system, a dialysis machine, and an interface providing an electrical communication between the dialysis machine and the vehicle navigation system. The dialysis machine is configured to perform a dialysis treatment on a patient while the vehicle is operating. The vehicle can be a car, a train, a plane, or another vehicle.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a Continuation of U.S. patent application Ser. No.13/837,811, filed Mar. 15, 2013, which is incorporated herein in itsentirety by reference.

FIELD

The present invention relates to autonomous vehicles and machines andsystems configured to carry out extracorporeal blood treatmenttherapies.

BACKGROUND OF THE INVENTION

As vehicles move more and more toward autonomous operation, vehicleoperators are gaining more and more freedom to accomplish tasks andconcentrate on matters other than driving the vehicle. Although portabledialysis machines are known, no vehicle has been equipped with adialysis machine that is interfaced with a vehicle navigation system orwith an autonomous vehicle control system.

SUMMARY OF THE PRESENT INVENTION

According to one or more embodiments of the present invention, anautonomous vehicle is provided that comprises an autonomous vehiclecontrol system, a dialysis machine, and an interface providing anelectrical communication between the dialysis machine and the autonomousvehicle control system. The autonomous vehicle can comprise anautomobile, a hybrid car, an airplane, a train, a submarine, ahelicopter, a ship, a boat, a spacecraft, or any other vehicle. Thedialysis machine can be configured to perform a dialysis treatment on apatient while the autonomous vehicle is under the control of theautonomous vehicle control system. The autonomous vehicle can compriseat least one battery for powering one or more components of theautonomous vehicle, and the interface can provide an electricalcommunication between the at least one battery and the dialysis machine.The autonomous vehicle can further comprise a vehicle electrical system,and the dialysis machine can be hardwired into the vehicle electricalsystem. The autonomous vehicle control system can comprise an inputdevice with which a user can input a desired destination. The autonomousvehicle control system can be configured to calculate the amount of timerequired for the autonomous vehicle to reach the desired destination.The dialysis machine controller unit can comprise an input device withwhich a user can input a desired prescription therapy, and the dialysismachine controller unit can be configured to calculate a rate oftreatment that would be required to complete the inputted prescriptiontherapy within the amount of time calculated by the autonomous vehiclecontrol system. The dialysis machine controller unit can further beconfigured to determine whether the calculated rate of treatment iswithin acceptable limits, and if so, the dialysis machine controllerunit can be configured to permit the dialysis machine to carry out theinputted prescription therapy. If the controller unit determines thatthe calculated rate of treatment is not within acceptable limits, thedialysis machine controller unit can further be configured to preventthe dialysis machine from carrying out the inputted prescriptiontherapy.

The present invention also encompasses vehicles that are not autonomous,but that include a navigation system, a dialysis machine, and aninterface providing an electrical communication between the dialysismachine and the navigation system.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are intended to provide a further explanation of the presentinvention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the features and advantages of the presentdisclosure will be obtained by reference to the accompanying drawings,which are intended to illustrate, not limit, the present teachings.

FIG. 1 is a front view of the interior of a vehicle in accordance withone or more embodiments of the present invention, showing a dialysismachine mounted, in-part, in the vehicle dashboard.

FIG. 2 is a front view of a vehicle seat back incorporating a dialysismachine, in accordance with various embodiments of the presentinvention.

FIG. 3 is a flow chart depicting a process for enabling users to input aprescribed therapy for dialysis, to be completed while traveling to adestination, and options that can be selected by the user if the desiredtherapy is not available.

FIG. 4 is a flow chart depicting a process for enabling users to input aprescribed therapy to be completed while traveling to a destination, andoptions that can be selected by the user if there is insufficient fuelor power.

FIG. 5 is a flow chart depicting a process for enabling actions inresponse to an alarm signal, including different actions depending on astate of the alarm signal.

FIG. 6 is an exemplary fluid circuit diagram that can be used in avehicle and method in accordance with the present invention.

FIG. 7 is another exemplary fluid circuit diagram that can be used in avehicle and method in accordance with the present invention.

FIG. 8 is a schematic of diagram of an exemplary manifold that can beused in a vehicle and method in accordance with the present invention.

FIG. 9 is a front view of an embodiment of a controller unit for adialysis system showing the door open and the manifold installed.

FIG. 10 is a diagram of an exemplary disconnect monitoring system.

FIG. 11 is a flowchart defining an exemplary disconnection detectionprocess.

FIG. 12 is yet another exemplary fluid circuit diagram that can be usedin a vehicle and method in accordance with the present invention.

FIG. 13 is yet another exemplary fluid circuit diagram that can be usedin a vehicle and method in accordance with the present invention.

FIG. 14 is yet another exemplary fluid circuit diagram that can be usedin a vehicle and method in accordance with the present invention.

FIG. 15 is a flowchart depicting a process for enabling users toaccurately add additives in a dialysis machine that can be used in avehicle and method in accordance with the present invention.

FIG. 16 is a schematic diagram showing a disposable kit comprising amanifold and a dialyzer attached to a plurality of tubes, which can beused in a vehicle and method in accordance with the present invention.

FIG. 17 is yet another exemplary fluid circuit diagram that can be usedin a vehicle and method in accordance with the present invention.

FIG. 18 is yet another exemplary fluid circuit diagram showing a primingmode of operation that can be used in a vehicle and method in accordancewith the present invention.

FIG. 19 is a schematic diagram of yet another embodiment of an exemplarymanifold that can be used in a vehicle and method in accordance with thepresent invention.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

According to one or more embodiments of the present invention, anautonomous vehicle is provided that comprises an autonomous vehiclecontrol system, a dialysis machine, and an interface providing anelectrical communication between the dialysis machine and the autonomousvehicle control system. The autonomous vehicle can comprise anautomobile, a hybrid car, an airplane, a train, a submarine, ahelicopter, a ship, a boat, a spacecraft, or any other vehicle. Thedialysis machine can be configured to perform a dialysis treatment on apatient while the autonomous vehicle is under the control of theautonomous vehicle control system. The autonomous vehicle can compriseat least one battery for powering one or more components of theautonomous vehicle, and the interface can provide an electricalcommunication between the at least one battery and the dialysis machine.The autonomous vehicle can further comprise a vehicle electrical system,and the dialysis machine can be hardwired into the vehicle electricalsystem. The autonomous vehicle control system can comprise an inputdevice with which a user can input a desired destination. The autonomousvehicle control system can be configured to calculate the amount of timerequired for the autonomous vehicle to reach the desired destination.The dialysis machine controller unit can comprise an input device withwhich a user can input a desired prescription therapy, and the dialysismachine controller unit can be configured to calculate a rate oftreatment that would be required to complete the inputted prescriptiontherapy within the amount of time calculated by the autonomous vehiclecontrol system. The dialysis machine controller unit can further beconfigured to determine whether the calculated rate of treatment iswithin acceptable limits, and if so, the dialysis machine controllerunit can be configured to permit the dialysis machine to carry out theinputted prescription therapy. If the controller unit determines thatthe calculated rate of treatment is not within acceptable limits, thedialysis machine controller unit can further be configured to preventthe dialysis machine from carrying out the inputted prescriptiontherapy.

The input device for the autonomous vehicle control system can comprisea display screen in the autonomous vehicle, and the input device for thedialysis machine can comprise the same display screen or a differentdisplay screen. The dialysis machine can further comprise a transmitterand a receiver, wherein the transmitter is configured to transmitwireless signals pertaining to the dialysis machine, and the receiver isconfigured to receive wireless signals pertaining to the dialysismachine. As such, a patient can be constant contact with a monitoringservice or clinic, during a therapy.

The autonomous vehicle can comprise an engine, and the autonomousvehicle control system can be configured to maintain the engine in arunning condition while the dialysis machine is operating. Theautonomous vehicle can comprise a battery-operated drive motorconfigured to move the autonomous vehicle. The autonomous vehicle canfurther comprise a vehicle electrical system, a car battery, analternator for charging the car battery during operation of the vehicle,and a backup battery dedicated to the dialysis machine. Then backupbattery can be in electrical communication with the alternator, and thevehicle electrical system can be configured to charge the backup batteryduring operation of the vehicle. The vehicle electrical system cancomprise an ignition switch and an ignition switch bypass circuitconfigured to provide battery power from the backup battery to thedialysis machine in the event that the ignition switch is turned offduring a prescription therapy.

The dialysis machine can comprise a blood flow circuit comprising: ablood pump; a dialyzer; an arterial tube; and a venous tube. Thearterial tube and the venous tube can be configured to be connectable toa patient blood flow system. The dialysis machine can further comprise adialysate flow circuit comprising: a dialysate pump; a fresh dialysatetube; and a spent dialysate tube, wherein the fresh dialysate tube andthe spent dialysate tube are configured to be connectable to thedialyzer. The dialysis machine can also comprise an alarm systemconfigured to transmit a signal, indicative of an alarm condition, to areceiver. The receiver can comprise a receiver at a hospital, a receiverat a clinic, a receiver at a medical monitoring service, or a receiverat another emergency care center. The dialysis machine alarm system canbe configured to determine the nearest hospital, dialysis clinic, urgentcare center, or other emergency care center, and navigate the autonomousvehicle to the nearest hospital, dialysis clinic, urgent care center, orother emergency care center, for corrective measures. Navigation to anemergency care center can be instigated if an emergency state alarmcondition is triggered. The dialysis machine alarm system can compriseat least one of an arterial chamber transducer and a venous chambertransducer, configured for monitoring blood flow pressure changes. In anexample, the dialysis machine can comprise at least one blood pump, thedialysis machine alarm system can comprise an arterial chambertransducer in a blood flow circuit, and the arterial chamber transducercan be configured such that, if it registers a pressure change that isoutside of a threshold limit, the alarm system stops the at least oneblood pump. Similarly, the dialysis machine can comprise at least oneblood pump, the dialysis machine alarm system can comprise a venouschamber transducer in a blood flow circuit, and the venous chambertransducer can be configured such that, if it registers a pressurechange that is outside of a threshold limit, the alarm system stops theat least one blood pump.

The dialysis machine can comprise a blood flow circuit comprising: ablood pump; a dialyzer; an arterial tube configured to be connectable toa patient blood flow system; a venous tube configured to be connectableto a patient blood flow system; and an emergency state alarm systemoperably configured to indicate an emergency condition. The emergencystate alarm system can be configured such that, upon activation, theautonomous vehicle control system navigates the autonomous vehicle to ahospital, a dialysis clinic, an urgent care center, or another emergencycare center, for corrective measures. For example, the autonomousvehicle control system can be configured such that, upon activation ofthe emergency state alarm system, the autonomous vehicle control systemdetermines the nearest emergency care center, and navigates theautonomous vehicle to the nearest emergency care center, for correctivemeasures. The autonomous vehicle control system can be configured suchthat, upon activation of the emergency state alarm system, theautonomous vehicle control system determines the nearest emergency carecenter, sends a notification to the nearest emergency care center sodetermined, and navigates the autonomous vehicle to the nearestemergency care center for corrective measures, the notificationpertaining to the emergency condition that triggered the activation ofthe emergency state alarm system.

The dialysis machine can further comprise an arterial tube pressuresensor, a venous tube pressure sensor, and an alarm system configured toindicate an alarm condition when one or both of the arterial tubepressure sensor and the venous tube pressure sensor senses a pressurethat exceeds a maximum respective threshold value or that drops below aminimum respective threshold value. The dialysis machine can comprise atleast one blood pump and an alarm system, wherein the alarm system isconfigured to (1) stop operation of at least one blood pump in responseto receiving a low level alarm signal, and (2) navigate the autonomousvehicle to the nearest emergency care center in response to receiving anemergency state alarm signal.

The autonomous vehicle can further comprise an engine, a fuel source forthe engine, a fuel sensor configured to sense the amount of fuelavailable for the engine, and a dialysis controller for the dialysismachine. The dialysis controller can comprise a user interfaceconfigured to enable a user to input a prescription therapy to thedialysis machine. The interface between the dialysis machine and theautonomous vehicle control system can comprise an electricalcommunication between the fuel sensor and the dialysis controller. Thefuel sensor can be configured to send a signal to the dialysiscontroller indicating the amount of fuel available to power the engine,and the dialysis controller can be configured to notify the user ifthere is insufficient fuel to power the engine for the amount of timethat would be required to carry out the prescription therapy. Thedialysis controller can be configured to calculate the amount of fuelthat would be required to operate the autonomous vehicle for a period oftime required to carry out the prescription therapy, and then notify theuser if there is insufficient fuel to power the engine for the amount oftime that would be required to carry out the prescription therapy. Thedialysis controller can be configured to calculate the amount of fuelbased on a measured current rate of consumption and based on a predictedrate of consumption that would be required to operate the autonomousvehicle and the dialysis machine together for the amount of time thatwould be required to carry out the prescription therapy. The dialysiscontroller can further be configured to prevent the dialysis machinefrom carrying out the prescription therapy if there is insufficient fuelto power the engine for the amount of time that would be required tocarry out the prescription therapy.

The autonomous vehicle can comprise a battery-operated motive engine, abattery configured to supply battery power to the engine, a batterysensor configured to sense the amount of battery power available for theengine, and a dialysis controller for the dialysis machine. The dialysiscontroller can comprise a user interface configured to enable a user toinput a prescription therapy to the dialysis machine. The interfacebetween the dialysis machine and the autonomous vehicle control systemcan comprise an electrical communication between the battery sensor andthe dialysis controller, and the battery sensor can be configured tosend a signal to the dialysis controller indicating the amount ofbattery power available to power the engine. The dialysis controller canbe configured to notify the user if there is insufficient battery powerto power the engine for the amount of time that would be required tocarry out the prescription therapy. The dialysis controller can beconfigured to calculate the amount of battery power that would berequired to operate the autonomous vehicle for a period of time requiredto carry out the prescription therapy, and then notify the user if thereis insufficient battery power to power the engine for the amount of timethat would be required to carry out the prescription therapy. Moreover,the dialysis controller can be configured to calculate the amount ofbattery power based on a measured current rate of consumption and basedon a predicted rate of consumption that would be required to operate theautonomous vehicle and the dialysis machine together for the amount oftime that would be required to carry out the prescription therapy. Thedialysis controller can further be configured to prevent the dialysismachine from carrying out the prescription therapy if there isinsufficient battery power to power the engine for the amount of timethat would be required to carry out the prescription therapy.

The dialysis machine can comprise a recirculating dialysate fluidcircuit and a sorbent cartridge in fluid communication with therecirculating dialysate fluid circuit. The autonomous vehicle cancomprise an engine and an engine cooling system. The dialysis machinecan comprise at least one fluid flow path, and the interface can beconfigured to use heat from the engine cooling system to heat one ormore fluids flowing through the at least one fluid flow path. The enginecooling system can comprise an engine coolant flow path, and theinterface can provide a heat-exchange communication between the enginecoolant flow path and the at least one fluid flow path of the dialysismachine. The at least one fluid flow path of the dialysis machine cancomprise a dialysate flow path and the interface can comprise a heatexchanger that is in thermal communication with the engine coolant flowpath and the dialysate flow path. The dialysis machine can comprise adialysate fluid flow path and a heater that is in thermal communicationwith the dialysate fluid flow path to heat dialysate fluid in thedialysate fluid flow path. The heater can comprise a resistance heater,an electrical heater, a radiant heater, a Peltier heater, or the like.

According to one or more embodiments of the present invention, anautonomous vehicle is provided that comprises a vehicle interior, anautonomous vehicle control system, a dialysis machine, and an interfaceproviding an electrical communication between the dialysis machine andthe autonomous vehicle control system. The dialysis machine can beconfigured to perform a dialysis treatment on a patient while theautonomous vehicle is under the control of the autonomous vehiclecontrol system. The dialysis machine can comprise, for example: acontrol unit; and a receiver fixedly attached to the vehicle interiorand configured to receive disposable dialysis equipment. The autonomousvehicle can further comprise a vehicle electrical system and thedialysis machine can be hardwired into the vehicle electrical system.The dialysis machine can include disposable dialysis equipment, forexample, comprising a molded plastic manifold defining a first flow pathand a second flow path that is fluidically isolated from the first flowpath. The molded plastic manifold can be received by the receiver. Thedisposable dialysis equipment can further comprise a dialyzer and themolded plastic manifold can be bonded to a plurality of tubes, whereinat least two of the tubes are in fluid communication with the dialyzer.A dialyzer mount can be fixedly attached to the vehicle interior andconfigured to fixedly secure the dialyzer with respect to the dialysismachine. The disposable dialysis equipment can further comprise asorbent cartridge, and the molded plastic manifold can be bonded to aplurality of tubes, at least two of which are in fluid communicationwith the sorbent cartridge. A cartridge mount can be fixedly attached tothe vehicle interior and configured to fixedly secure the sorbentcartridge with respect to the dialysis machine.

The dialysis machine can further comprise: a door having an interiorface; and a housing built into the interior of the vehicle and includinga panel. The housing and the panel can be configured so that togetherthey define a recessed region adapted to receive the interior face ofthe door. The receiver can be fixedly attached to the panel. The panelcan be configured to provide access to a plurality of pumps, and thedialysis machine can further comprise pumps, for example, at least oneblood pump and at least one dialysate pump. The pumps can be operablypositioned in substantially parallel alignment with one another, and thepanel can be configured to provide access to the pumps. The interiorface of the door can comprise pump shoes that align with the pumps whenthe door is in a closed position. The door can have an exterior face andthe control unit can be mounted on the exterior face of the door.

The dialysis machine can further comprise a surface for receiving acontainer of fluid. The surface can be built into a floor or a seat ofthe autonomous vehicle. A scale can be integrated into the surface andconfigured to weigh a container of fluid disposed on the surface. Aheater can be provided in thermal communication with the surface, and aconductivity sensor can be provided in electromagnetic communicationwith the surface. In some cases, the autonomous vehicle comprises a dashboard and the control unit is mounted in or on the dash board. Thecontrol unit can comprise a graphical user interface, and the graphicaluser interface can be mounted in or on the dash board.

The dialysis machine can further comprise a plurality of connectors, andan electronic circuit element. The electronic circuit element cancomprise a processor module, a data acquisition module in electricalcommunication with the processor module, and an interface module inelectronic communication with the data acquisition module. Theelectronic circuit element can comprise a video module, a touch panelelement in electrical communication with the video module, a pulsedisplay, one or more pressure displays, an electrocardiogram display, acombination thereof, or the like. The plurality of connectors cancomprise a blood pressure device input, a pulse device input, an EKGdevice input, a combination thereof, or the like. The autonomous vehiclecan further comprise a catch basin, the vehicle interior can comprise afloor, the dialysis machine can comprise a plurality of connectors, thecatch basin can be secured to the floor, and the catch basin can bepositioned with respect to the dialysis machine to catch liquid thatdrips from the connectors in the event that liquid drips from one ormore of the plurality of connectors. The catch basin can be removablysecured to the floor. The catch basin can be removably secured to a seatin the vehicle.

According to one or more embodiments of the present invention, thevehicle can be, but is not necessarily, an autonomous vehicle. Althoughreferred to below as a non-autonomous vehicle to distinguish from someof the embodiments described above, it is to be understood that thefeatures described below could similarly be incorporated into anautonomous vehicle and doing so is well within the scope of the presentinvention.

The non-autonomous vehicle can comprise an automobile, a hybrid car, anairplane, a train, a submarine, a helicopter, a ship, a boat, aspacecraft, or the like. The vehicle can comprise a vehicle navigationsystem, a dialysis machine, and an interface providing an electricalcommunication between the dialysis machine and the vehicle navigationsystem. The dialysis machine can be configured to perform a dialysistreatment on a patient while the vehicle is operating. The dialysismachine can comprise: a controller; a door having an interior face; ahousing built into the interior of the vehicle and including a panel,wherein the housing and the panel define a recessed region that facesthe interior face of the door; and a disposables circuit receiverattached to the panel. The vehicle can further comprise a vehicleelectrical system, and the dialysis machine can be hardwired into thevehicle electrical system. The vehicle can comprise at least one batteryfor powering one or more components of the vehicle, and the interfacecan provide an electrical communication between the at least one batteryand the dialysis machine.

The vehicle navigation system can comprise an input device with which auser can input a desired destination. The vehicle navigation system canbe configured to calculate the amount of time required for the vehicleto reach the desired destination. The dialysis machine can comprise aninput device with which a user can input a desired prescription therapy.The dialysis machine can also comprise a control unit configured tocalculate a rate of treatment that would be required to complete theinputted prescription therapy within the amount of time calculated bythe vehicle navigation system. The dialysis machine control unit canfurther be configured to determine whether the calculated rate oftreatment is within acceptable limits, and if so, the dialysis machinecontrol unit can be configured to permit the dialysis machine to carryout the inputted prescription therapy. If the control unit determinesthat the calculated rate of treatment is not within acceptable limits,the dialysis machine control unit can be configured to prevent thedialysis machine from carrying out the inputted prescription therapy.

The dialysis machine can further comprise a transmitter and a receiver.The transmitter can be configured to transmit wireless signalspertaining to the dialysis machine, and the receiver can be configuredto receive wireless signals pertaining to the dialysis machine. Thevehicle can comprise a vehicle electrical system, a battery, analternator for charging the battery during operation of the vehicle, anda backup battery dedicated to the dialysis machine. The backup batterycan be in electrical communication with the alternator and the vehicleelectrical system can be configured to charge the backup battery duringoperation of the vehicle. The vehicle electrical system can comprise anignition switch and an ignition switch bypass circuit configured toprovide battery power from the backup battery to the dialysis machine inthe event that the ignition switch is turned off.

Similar to the autonomous vehicles discussed above, the dialysis machinein the non-autonomous vehicle can also comprise an emergency state alarmsystem operably configured to indicate an emergency condition. Uponactivation of the emergency state alarm system, the vehicle navigationsystem can be caused to navigate the vehicle to an emergency carecenter, for corrective measures. Upon activation of the emergency statealarm system, the vehicle navigation system can determine the nearestemergency care center and navigate the vehicle to the nearest emergencycare, center for corrective measures. In some cases, upon activation ofthe emergency state alarm system, the vehicle control system candetermine the nearest emergency care center, send a notification to thenearest emergency care center so determined, and navigate the vehicle tothe nearest emergency care center, for corrective measures. Thenotification can pertain to the emergency condition that triggered theactivation of the emergency state alarm system.

The dialysis machine can further comprise an arterial tube pressuresensor, a venous tube pressure sensor, and an alarm system configured toindicate an alarm condition when one or both of the arterial tubepressure sensor and the venous tube pressure sensor senses a pressurethat exceeds a maximum respective threshold value or that drops below aminimum respective threshold value. The dialysis machine can comprise atleast one blood pump, and such an alarm system. The alarm system can beconfigured to (1) stop operation of the at least one blood pump inresponse to receiving a low level alarm or a high level alarm signal,and (2) navigate the vehicle to the nearest emergency care center inresponse to receiving an emergency state alarm signal. The dialysismachine alarm system can further be configured to transmit a signal,indicative of an alarm condition, to a receiver. The receiver cancomprise a receiver at a hospital, a receiver at a clinic, a receiver ata medical monitoring service, or a receiver at another emergency carecenter. The dialysis machine can include an alarm system that comprisesat least one of an arterial chamber transducer and a venous chambertransducer, in a blood flow path, which are configured for monitoringblood flow pressure changes.

The vehicle can comprise an engine, a fuel source for the engine, a fuelsensor configured to sense the amount of fuel available for the engine,and a dialysis control unit for the dialysis machine. The dialysiscontrol unit can comprise a user interface configured to enable a userto input a prescription therapy to the dialysis machine, the interfacebetween the dialysis machine and the vehicle navigation system cancomprise an electrical communication between the fuel sensor and thedialysis control unit. The fuel sensor can be configured to send asignal to the dialysis control unit indicating the amount of fuelavailable to power the engine. The dialysis control unit can beconfigured to notify the user if there is insufficient fuel to power theengine for the amount of time that would be required to carry out theprescription therapy. In some cases, the dialysis control unit can beconfigured to calculate the amount of fuel that would be required tooperate the vehicle for a period of time required to carry out theprescription therapy, and then notify the user if there is insufficientfuel to power the engine for the amount of time that would be requiredto carry out the prescription therapy. The dialysis control unit can beconfigured to calculate the amount of fuel based on a measured currentrate of consumption and based on a predicted rate of consumption thatwould be required to operate the vehicle and the dialysis machinetogether for the amount of time that would be required to carry out theprescription therapy. The dialysis control unit can be configured toprevent the dialysis machine from carrying out the prescription therapyif there is insufficient fuel to power the engine for the amount of timethat would be required to carry out the prescription therapy.

In cases where the vehicle comprises a battery-operated motive engine, abattery is provided to supply battery power to the engine. A batterysensor can be configured to sense the amount of battery power availablefor the engine, and a dialysis control unit for the dialysis machine cancomprise a user interface configured to enable a user to input aprescription therapy to the dialysis machine. The interface between thedialysis machine and the vehicle navigation system can comprise anelectrical communication between the battery sensor and the dialysiscontrol unit. The battery sensor can be configured to send a signal tothe dialysis control unit indicating the amount of battery poweravailable to power the engine, and the dialysis control unit can beconfigured to notify the user if there is insufficient battery power topower the engine for the amount of time that would be required to carryout the prescription therapy. The dialysis control unit can beconfigured to calculate the amount of battery power that would berequired to operate the vehicle for a period of time required to carryout the prescription therapy, and then notify the user if there isinsufficient battery power to power the engine for the amount of timethat would be required. The dialysis control unit can be configured tocalculate the amount of battery power based on a measured current rateof consumption and based on a predicted rate of consumption that wouldbe required to operate the vehicle and the dialysis machine together forthe amount of time that would be required to carry out the prescriptiontherapy. The dialysis control unit can further be configured to preventthe dialysis machine from carrying out the prescription therapy if thereis insufficient battery power to power the engine for the amount of timethat would be required to carry out the therapy.

Similar to the autonomous vehicles discussed above, the non-autonomousvehicle can further comprise a catch basin. The vehicle interior cancomprise a floor, the dialysis machine can comprise a plurality ofconnectors, and the catch basin can be secured to the floor in aposition with respect to the dialysis machine such that the catch basincan catch any liquid that drips from the connectors in the event thatone or more of the connectors leaks. The catch basin can be removablysecured to the floor, removably secured to a seat in the vehicle,removably secured in a trunk of the vehicle, or the like.

The vehicle can further comprise a dash board, and the dialysis machinecan comprise a graphical user interface mounted in or on the dash board.The dialysis machine can further comprise a front panel havingassociated therewith an electronic circuit element. The electroniccircuit element can comprise a processor module, a data acquisitionmodule in electrical communication with the processor module, aninterface module in electronic communication with the data acquisitionmodule, a video module, a touch panel element in electricalcommunication with the video module, a pulse display, an EKG display, acombination thereof, or the like. The dialysis machine can furthercomprise a front panel having associated therewith a plurality ofconnectors comprising a blood pressure device input, a pulse deviceinput, an EKG device input, a combination thereof, or the like.

With reference to the drawings, FIG. 1 is a front view of an interior100 of a vehicle in accordance with one or more embodiments of thepresent invention. While the vehicle can be an autonomous vehicle, itdoes not have to be. The vehicle includes a dashboard 102, a dialysismachine 104 mounted in or on dashboard 102, and a user interface 106that can be used for programming dialysis machine 104 and a vehiclenavigation system. User interface 106 can include a keyboard 108, adisplay screen 110, a microphone, and quick control buttons 136 forcontrolling display screen 110. Display screen 110 can be a shareddisplay screen for displaying user prompts, inquiries, instructions, andthe like information. Display screen 110 can be split, for example, as afunction of one or more of quick control buttons 136. Navigationinformation 112 and dialysis therapy information 114 can simultaneouslybe displayed by using a split screen function. One or more buttons orfeatures can be included to gain access to a voice-activation systemthat can be used to input information. The information can include, forexample, vehicle navigation instructions, dialysis therapy instructions,other information, a combination thereof, and the like.

Dialysis machine 104 can comprise a blood pump 120, a dialysate pump122, a dialyzer 124, a sorbent cartridge 126, an anti-coagulantinjection system 128, a pressure sensor 130, and a drip chamber 132. Oneor more of the dialysis machine components can be provided as adisposable. Many of the dialysis machine components can be providedtogether as a disposable kit.

The vehicle in which dialysis machine 104 is mounted can include anavigation system for which information can be displayed on displayscreen 110. In FIG. 1, navigation information 112 is displayed onright-hand side of display screen 110, and display screen 110 isconfigured for a split screen display. The left-hand side of displayscreen 110 can display information, user prompts, inquiries,instructions, and the like, pertaining to a dialysis therapy to becarried out by dialysis machine 104.

A door, not shown, can be used to encase and protect dialysis machine104 within a recess 150 that is provided in dashboard 102. Access todialysis machine 104 can be gained, for example, by a lock on the door,or by a latch, for example, that includes a handle disposed within aglove box 134.

The dialysate circuit of dialysis machine 104 can include a to-reservoirline 140 and a from-reservoir line 142 that are in fluid communicationwith a remote reservoir (not shown). The remote reservoir can bedisposed, for example, in glove box 134, in a trunk of the vehicle, in aback seat of the vehicle, in the passenger seat, mounted elsewhere inthe dashboard, or in another suitable location of the vehicle. Thereservoir can be operationally associated with a heater, a scale, orboth. For example, the reservoir can be disposed on top of a heater anda scale. Dialysis machine 104 can further include a from-patient venouscatheter line 144 and a to-patient arterial catheter line 146 forconnection of dialysis machine 104 to a patient. Venous catheter line144 and arterial catheter line 146 can be included in a disposables kit,for example, in a kit that further includes dialyzer 124, sorbentcartridge 126, anti-coagulant injection system 128, drip chamber 132,and interconnecting tubing. Any number of different disposables kits canbe configured to operate in conjunction with dialysis machine 104, andmany are described below. Different kits can be provided to carry outdifferent therapies.

Information pertaining to operation of the vehicle can be displayed in avehicle operation information display panel 138. The information caninclude, for example, speed, rpm, oil temperature, oil pressure, outsidetemperature, and the like. According to one or more embodiments of thepresent invention, the vehicle navigation system and dialysis machine104 can be interfaced such that a dialysis therapy can be carried out ona patient while the vehicle transports the patient to a destination.

FIG. 2 is a front view of a vehicle seat 200 in accordance with one ormore embodiments of the present invention. Vehicle seat 200 includes adialysis machine 204 incorporated therein. Dialysis machine 204 can beset in, or wholly or partially recessed within, a recess 250 formed invehicle seat 200. In the embodiment depicted, dialysis machine 204 isrecessed into the back of vehicle seat 200, although other positions canbe used.

While the vehicle seat can be provided in an autonomous vehicle, thevehicle does not have to be autonomous. Dialysis machine 204 can beprovided with a user interface, and in an exemplary embodiment, the userinterface can comprise a touch screen, for example, display screen 210can also be used as a touch screen input device that can be used forprogramming dialysis machine 204. Dialysis machine 204 can be interfacedwith a vehicle navigation system so that a therapy would not beauthorized if the vehicle is expected to arrive at a desired destinationbefore a requested therapy can be completed. Although not shown, theuser interface can also or instead include a keyboard, a microphone, ajoy stick, a combination thereof, or the like.

Display screen 210 can be controlled, at least in-part, by quick controlbuttons 236. Display screen 210 can be a shared display screen fordisplaying user prompts, inquiries, instructions, and the likeinformation. Display screen 210 can be split, for example, as a functionof one or more of quick control buttons 236. Although only dialysistherapy information 214 is displayed on display screen 210, in FIG. 2,it is to be understood that navigation information and dialysis therapyinformation can simultaneously be displayed by using a split screenfunction. One or more buttons or features can be included to gain accessto a voice-activation system that can be used to input information. Theinformation can include, for example, vehicle navigation instructions,dialysis therapy instructions, other information, a combination thereof,and the like.

Dialysis machine 204 can comprise a blood pump 220, a dialysate pump222, a dialyzer 224, a sorbent cartridge 226, an anti-coagulantinjection system 228, a pressure sensor 230, and a drip chamber 232. Oneor more of the dialysis machine components can be provided as adisposable. Many of the dialysis machine components can be providedtogether as a disposable kit.

The vehicle in which vehicle seat 200 and dialysis machine 204 aremounted can include a navigation system for which information can bedisplayed on display screen 210, for example, navigation information canbe displayed on a right-hand side of display screen 210 while therapyinformation can be displayed on the left-hand side of display screen210. The information can include user prompts, inquiries, instructions,warnings, alarm signals, and the like, pertaining to a dialysis therapyto be carried out, or being carried out, by dialysis machine 204.

A door, not shown, can be used to encase and protect dialysis machine204 within recess 250. Access to dialysis machine 204 can be gained, forexample, by a lock on the door, or by a latch, for example, thatincludes a handle. A hinge can be provided spaced from, but close to,the edge 252 of vehicle seat 200. The hinge can be provided to hingedlyattach the door to recess 250 or elsewhere to vehicle seat 200.

The dialysate circuit of dialysis machine 204 can include a to-reservoirline 240 and a from-reservoir line 242 that are in fluid communicationwith a reservoir 260. The reservoir can alternatively be disposed, forexample, in a glove box, under vehicle seat 200, in a trunk of thevehicle, in a back seat of the vehicle, in a passenger seat of thevehicle, in a cargo hold, or in another suitable location of thevehicle. The reservoir can be operationally associated with a heater, ascale, or both. For example, as shown, a heating and weighing system 270can be provided underneath reservoir 260, for heating and weighing thecontents of reservoir 260. A conductivity sensor 272 can also beprovided for measuring the conductivity of dialysate in the reservoir.

Dialysis machine 204 can further include a from-patient venous catheterline 244 and a to-patient arterial catheter line 246 for connection ofdialysis machine 204 to a patient. The patient can sit, for example, ina seat directly behind vehicle seat 200, during therapy. Venous catheterline 244 and arterial catheter line 246 can be included in a disposableskit, for example, in a kit that further includes dialyzer 224, sorbentcartridge 226, anti-coagulant injection system 228, drip chamber 232,and interconnecting tubing. Any number of different disposables kits canbe configured to operate in conjunction with dialysis machine 204, andmany are described below. Different kits can be provided to carry outdifferent therapies.

FIG. 3 is a flow chart depicting a process for enabling a user to inputa prescribed therapy for dialysis, which is to be completed while theuser is traveling to a destination. Initially, a user can input aprescription therapy to be carried out, and a destination. Althougheither the therapy or the destination can be input first, FIG. 3 depictsinputting the prescription therapy as a first step 300, followed by astep 302 for inputting a destination. The therapy and/or destination canbe input using voice activation, a keyboard, a touch screen, a joystick,a combination thereof, or the like. The vehicle navigation system can beprovided with a processor and a global positioning system (GPS), whichtogether can be used to calculate an arrival time, as depicted in step304. During travel, adjustments to the calculated arrival time can bemade and one or more revised arrival times can be displayed.

As depicted in step 306, the processor can determine, based on theinputted prescription therapy and the calculated arrival time, whetherthe requested therapy can be completed before the arrival time. If so, adialysis machine display screen can be used to display a message such as“Press START to proceed with therapy,” as depicted in step 308. If theprocessor determines that the requested therapy cannot be completedbefore the arrival time, in step 306, then the display can be powered toshow a message such as “Insufficient time until arrival to completetherapy,” as depicted in step 310. If the processor, or an associateddata store, memory, or other source of data, indicates that optionaltherapies are available that can be completed before the calculatedarrival time, the processor can power the display to show a message suchas “Show therapies that can be completed before arrival time?”, asdepicted in step 312. If there are alternative therapies available, thesystem can be configured to display the different options and the usercan be prompted to select one of the alternative therapies, or cancelprogramming. If the user does not want to see a listing of alternativetherapies that are available, the user can input “No” in response to thequery of step 314, and in response, the system can be configured todisplay a message such as “Press GO to proceed to destination,” asdepicted in step 316.

If alternative therapies are available and the user wants to see them,the user can input a YES command in response to the query of step 314and the processor can calculate and display the alternative therapiesthat can be completed before the arrival time. Calculating the therapiesis depicted in step 318 and displaying the therapies is depicted in step320. Once the alternative therapies are displayed, the user can beprompted to select one of the alternative therapies, and the selectioncan be input in a step 322. Once an alternative therapy is selected, thedisplay can be powered to show a message such as “Press START to proceedwith therapy,” as depicted in step 324.

FIG. 4 is a flow chart depicting a process for enabling a user to inputa prescribed therapy for dialysis, to be completed while traveling to adestination. In the process depicted in FIG. 4, a vehicle informationsystem is interfaced with a dialysis machine control system and aprocessor can be used to determine whether there is sufficient fuel,battery power, other energy source, or a combination thereof, to operatethe vehicle for the length of time that would be required to completethe requested dialysis therapy. While many energy sources can be used,the sources are exemplified as fuel (or power) in FIG. 4. As depicted inFIG. 4, a prescription for a dialysis therapy can be input into aprocessor, as shown in step 400. The processor can then calculate, basedon the amount of available fuel, battery power, other energy source, orcombination thereof, whether the vehicle has sufficient fuel, batterypower, energy sources, or the like, to operate for the necessary lengthof time. The calculating is depicted in step 402. Once the fuel and/orbattery power has been compared to the amount needed to complete therequested prescription therapy, the processor then can respond to thequery shown in step 404, that is, whether the vehicle has sufficientfuel and/or battery power. If there is sufficient fuel and/or batterypower, the processor can send a signal to display a message such as,“Press START to proceed with therapy,” as depicted in step 406.

If the processor determines that the requested therapy cannot becompleted based on the available fuel or power, in step 404, then thedisplay can be powered to show a message such as “Insufficient fuel (orpower) to complete therapy,” as depicted in step 408. If the processor,or an associated data store, memory, or other source of data, indicatesthat optional therapies are available that can be completed with theavailable fuel or power, the processor can power the display to show amessage such as “Show therapies that can be completed with availablefuel (or power)?”, as depicted in step 410. If there are alternativetherapies available, the system can be configured to display thedifferent options and the user can be prompted to select one of thealternative therapies, or cancel programming. If the user does not wantto see a listing of alternative therapies that are available, the usercan input “No” in response to the query of step 412, and in response,the system can be configured to display a message such as “Therapycanceled,” as depicted in step 414.

If alternative therapies are available and the user wants to see them,the user can input a YES command in response to the query of step 412and the processor can calculate and display the alternative therapiesthat can be completed based on the available fuel or power. Calculatingthe therapies is depicted in step 416 and displaying the therapies isdepicted in step 418. Once the alternative therapies are displayed, theuser can be prompted to select one of the alternative therapies, and theselection can be input in a step 420. Once an alternative therapy isselected, the display can be powered to show a message such as “PressSTART to proceed with therapy,” as depicted in step 422.

FIG. 5 is a flow chart depicting a process for enabling one or moredialysis machine and/or vehicle actions in response to an alarm signal.As described in greater detail below, the dialysis machine incorporatedin the vehicle can be provided with an alarm system configured togenerate one or more alarm signals indicative of one or more,respective, alarm states. As with conventional dialysis machines, thedialysis machine can be provided with sensors for detecting leaks,occlusions, air bubbles, loss of pressure, disconnect, elevatedpressure, blood pulse, electrocardiogram, or other conditions andparameters. In many cases, a low level alarm signal can be generated forconditions that can be easily corrected by the user. In some cases,however, a more serious condition can trigger an emergency state alarmsignal, for example, indicative of a grave situation needing immediateattention and which the user may not be able to correct. An exemplarycondition that might trigger an emergency state alarm signal would be alack of pulse, a lack of heart beat, a lack of arterial pressure, or avehicle collision. As shown in FIG. 5, the alarm system can beprogrammed to receive an alarm signal in step 500, and determine whetherthe alarm signal is an emergency state signal, as depicted in step 502.If the alarm signal is an emergency state alarm signal, the alarm systemcan be configured to calculate the nearest emergency care center, asdepicted in FIG. 504, and navigate the vehicle to the nearest emergencycare center, as depicted in step 506. The alarm system can display amessage such as “Proceeding to nearest emergency care center,” asdepicted in step 508. The alarm system can further be configured toprovide additional information, for example, by displaying the name,address, and phone number of the nearest emergency care center to whichthe vehicle is being navigated, as depicted is step 510. The alarmsystem can be configured to automatically call a help hotline or 911.

If, the alarm system determines that the alarm signal is not for anemergency state, in step 502, then the alarm system can be configured tostop the blood pump as depicted in step 512 and display a message suchas “Check connections, check for occlusion, check for air bubbles,” asdepicted in step 514. The user is thus prompted to take correctiveaction as depicted in step 516, for example, to reestablish aconnection, to remove an air bubble, to adjust the position of acatheter in a vein or artery, or the like. After taking the correctiveaction, the user can then enter a “Proceed” command and the alarm systemcan then test for the condition that caused the low level alarm signal.Testing for the condition is depicted in step 518. If the condition iscorrected, as queried in step 520, then the alarm system can be reset asdepicted in step 522. If, however, the condition is not corrected inresponse to the user's corrective actions, then the system can beconfigured to again display a message such as “Check connections, checkfor occlusion, check for air bubbles,” as depicted in step 514, and thecorrective action sequence can be repeated. If, after a predefinednumber of attempts, the corrective actions of the user do not correctthe alarm condition, the user may be prompted to proceed to the nearestemergency care center.

FIGS. 6-19 show a variety of disposable kits, machines, machine andsystem components, fluid flow paths, and related features that can beincluded in the vehicles and used in the methods of the presentinvention. Other components, machines, systems, and methods that can beused in or a part of the present invention include those described inU.S. Patent Application Publication No. US 2011/0315611 A1 to Fulkersonet al., and US 2010/0022937 A1 to Bedingfield et al., which areincorporated herein in their entireties by reference. Moreover, otherdialysis components, machines, systems, and methods that can be used inor a part of the present invention include those described in U.S. Pat.No. 4,353,368 to Slovak et al., which is incorporated herein in itsentirety by reference. Furthermore, dialysis components, machines,systems, and methods related to peritoneal dialysis and which can beused in or as a part of the present invention include those described inU.S. Pat. No. 6,129,699 to Haight et al., U.S. Pat. No. 6,234,992 B1 toHaight et al., U.S. Pat. No. 6,284,139 B1 to Piccirillo, which areincorporated herein in their entireties by reference. Also, components,machines, systems, and methods for the autonomous control of vehicles,which can be used in or a part of the present invention include thosedescribed in U.S. Patent Application Publications Nos. US 2001/0055063A1 to Nagai et al., US 2012/0316725 A1 to Trepagnier et al., US2012/0101680 A1 to Trepagnier et al., US 2012/0035788 A1 to Trepagnieret al., US 2010/0106356 A1 to Trepagnier et al., US 2007/0219720 A1 toTrepagnier et al., and US 2012/0179321 A1 to Biber et al., which areincorporated herein in their entireties by reference.

FIG. 6 is a functional block diagram showing an embodiment of anultrafiltration treatment system 2800 that can be used in a vehicle ofthe present invention. As shown in FIG. 6, blood from a patient is drawninto blood inlet tubing 2801 by a pump, such as a peristaltic bloodpump, 2802 that forces the blood into a hemofilter cartridge 2804 viablood inlet port 2803. Inlet and outlet pressure transducers 2805, 2806are connected in-line just before and after the blood pump 2802. Thehemofilter 2804 comprises a semi-permeable membrane that allows excessfluid to be ultrafiltrated from the blood passing therethrough, byconvection. Ultrafiltered blood is further pumped out of the hemofilter2804 through blood outlet port 2807 into blood outlet tubing 2808 forinfusion back to into the patient. Regulators, such as clamps, 2809,2810 are used in tubing 2801 and 2808 to regulate fluid flowtherethrough.

A pressure transducer 2811 is connected near the blood outlet port 2807followed by an air bubble detector 2812 downstream from the pressuretransducer 2811. An ultrafiltrate pump, such as a peristaltic pump, 2813draws the ultrafiltrate waste from the hemofilter 2804 via UF(ultrafiltrate) outlet port 2814 and into the UF outlet tubing 2815. Apressure transducer 2816 and a blood leak detector 2817 are transposedinto the UF outlet tubing 2815. Ultrafiltrate waste is finally pumpedinto a waste collection reservoir 2818 such as a flask or soft bag,attached to the leg of an ambulatory patient and equipped with a drainport to allow intermittent emptying. The amount of ultrafiltrate wastegenerated can be monitored using any measurement technique, including ascale 2819 or flow meter. The microcontroller 2820 monitors and managesthe functioning of the blood and UF pumps, pressure sensors as well asair and blood leak detectors. Standard luer connections such as luerslips and luer locks are used for connecting tubing to the pumps, thehemofilter and to the patient.

Another blood and dialysate circuit capable of being implemented or usedin the embodiments of the dialysis systems is shown in FIG. 7. FIG. 7depicts the fluidic circuit for an extracorporeal blood processingsystem 2900, used for conducting hemodialysis and hemofiltration. In oneembodiment of the present invention, the system 2900 is implemented as aportable dialysis system, which may be used by a patient for conductingdialysis at home. The hemodialysis system comprises two circuits—a BloodCircuit 2901 and a Dialysate Circuit 2902. Blood treatment duringdialysis involves extracorporeal circulation through an exchanger havinga semi permeable membrane—the hemodialyser or dialyzer 2903. Thepatient's blood is circulated in the blood circuit 2901 on one side ofthe membrane (dialyzer) 2903 and the dialysate, comprising the mainelectrolytes of the blood in concentrations prescribed by a physician,is circulated on the other side in the dialysate circuit 2902. Thecirculation of dialysate fluid thus provides for the regulation andadjustment of the electrolytic concentration in blood.

The line 2904 from the patient, which transports impure blood to thedialyzer 2903 in the blood circuit 2901 is provided with an occlusiondetector 2905 which is generally linked to a visual or audible alarm tosignal any obstruction to the blood flow. In order to preventcoagulation of blood, delivery means 2906, such as a pump, syringe, orany other injection device, for injecting an anticoagulant—such asheparin, into blood is also provided. A peristaltic pump 2907 is alsoprovided to ensure flow of blood in the normal (desired) direction.

A pressure sensor 2908 is provided at the inlet where impure bloodenters the dialyzer 2903. Other pressure sensors 2909, 2910, 2911 and2912 are provided at various positions in the hemodialysis system totrack, and maintain, fluid pressure at desired levels at specific pointswithin the respective circuits.

At the point where used dialysate fluid from the dialyzer 2903 entersthe dialysate circuit 2902, a blood leak sensor 2913 is provided tosense and warn of any leakage of blood cells into the dialysate circuit.A pair of bypass valves 2914 is also provided at the beginning and endpoints of the dialysate circuit, so that under conditions of start up,or other as deemed necessary by the machine state or operator, thedialyzer can be bypassed from the dialysate fluid flow, yet thedialysate fluid flow can still be maintained, i.e. for flushing orpriming operations. Another valve 2915 is provided just before apriming/drain port 2916. The port 2916 is used for initially filling thecircuit with a dialysate solution, and to remove used dialysate fluidafter, and in some instances during, dialysis. During dialysis, valve2915 may be used to replace portions of used dialysate with highconcentrations of, for instance, sodium with replenishment fluid ofappropriate concentration so that overall component concentration of thedialysate is maintained at a desired level.

The dialysate circuit is provided with two peristaltic pumps 2917 and2918. Pump 2917 is used for pumping dialysate fluid to the drain orwaste container, as well as for pumping regenerated dialysate into thedialyzer 2903. Pump 2918 is used for pumping out spent dialysate fromthe dialyzer 2903, maintaining fluid pressure through the sorbent 2919,and pumping in dialysis fluid from port 2916 to fill the system ormaintain component concentration in the dialysate.

A sorbent cartridge 2919 is provided in the dialysate circuit 2902. Thesorbent cartridge 2919 contains several layers of materials, each havinga role in removing impurities, such as urea and creatinine. Thecombination of these layered materials allows water suitable fordrinking to be charged into the system for use as dialysate fluid. Italso allows closed loop dialysis. That is, the sorbent cartridge 2919enables regeneration of fresh dialysate from the spent dialysate comingfrom the dialyzer 2903. For the fresh dialysate fluid, a lined containeror reservoir 2920 of a suitable capacity such as 0.5, 1, 5, 8 or 10liters is provided.

Depending upon patient requirements and based on a physician'sprescription, desired quantities of an infusate solution 2921 can beadded to the dialysis fluid. Infusate 2921 is a solution containingminerals and/or glucose that help replenish minerals like potassium andcalcium in the dialysate fluid at levels after undesired removal by thesorbent. A peristaltic pump 2922 is provided to pump the desired amountof infusate solution 2921 to the container 2920. Alternatively, theinfusate solution 2921 can be pumped into the outflow line fromreservoir 2920. A camera 2923 may optionally be provided to monitor thechanging liquid level of the infusate solution as a safety check warningof infusate flow failure and/or function as a bar code sensor to scanbar codes associated with additives to be used in a dialysis procedure.

A heater 2924 is provided to maintain the temperature of dialysate fluidin the container 2920 at the required level. The temperature of thedialysate fluid can be sensed by the temperature sensor 2925 locatedjust prior to the fluids entry in to the dialyzer 2903. The container2920 is also equipped with a scale 2926 for keeping track of the weight,and therefore volume, of the fluid in the container 2920, and aconductivity sensor 2927, which determines and monitors the conductivityof the dialysate fluid. The conductivity sensor 2927 provides anindication of the level of sodium in the dialysate.

A medical port 2929 is provided before blood from the patient enters thesystem for dialysis. Another medical port 2930 is provided before cleanblood from the dialyzer 2903 is returned to the patient. An air (orbubble) sensor 2931 and a pinch clamp 2932 are employed in the circuitto detect and prevent any air, gas or gas bubbles from being returned tothe patient. Priming set(s) 2933 is/are attached to the dialysis system2900 that help prepare the system by filling the blood circuit 2901 withsterile saline before it is used for dialysis. Priming set(s) mayconsist of short segments of tubing with IV bag spikes or IV needles ora combination of both pre-attached.

It should be appreciated that, while certain of the aforementionedembodiments disclose the incorporation and use of a port that receivesan injection or administration of an anticoagulant, thereby creating anair-blood interface, such a port can be eliminated if the device canoperate with minimal risk of blood clotting at ports of entry and exit.As further discussed below, the manifold design, particularly withrespect to the internal design of the manifold ports, minimizes the riskof blood clotting, thereby creating the option of eliminating air-bloodinterfaces for receiving an injection or administration of ananticoagulant.

One of ordinary skill in the art would infer from the above discussionthat the exemplary fluidic circuits for a hemodialysis and/orhemofiltration system are complex. If implemented in a conventionalmanner, the system would manifest as a mesh of tubing and would be toocomplicated for a home dialysis user to configure and use. Therefore, inorder to make the system simple and easy to use at home by a patient,embodiments of the present invention implement the fluidic circuits inthe form of a compact manifold in which most components of the fluidiccircuit are integrated into a single piece of molded plastic or multiplepieces of molded plastic that are configured to connect together to forma single operative manifold structure.

FIG. 8 is a diagram detailing the fluidic circuit for the compactmanifold according to one embodiment of the present invention. Thefluidic circuit comprises four pump tube segments 3301, 3302, 3303 and3304 in pressure communication with pumps within the top controller unitand pump shoes in the top controller unit door. It further comprisesfive pressure membranes in pressure communication with pressure sensors3305, 3306, 3307, 3308 and 3309, and an area in thermal or opticalcommunication with a temperature sensor 3310. In the embodimentillustrated in FIG. 8, three pairs of membranes, shown at 3311, 3312 and3313, are integrated into the manifold. The membranes function as valveswhen they are occluded by a pin, member or protrusion from thecontroller unit.

Grouped in this manner the pairs of six one way valves form threetwo-way valve assemblies 3311, 3312, and 3313. The two-way valvesprovide greater flexibility in controlling the configuration of acircuit. When conventional two-way valves are used to occlude portionsof a fluid pathway, they are typically configured to enable twodifferent fluid pathways, one for a first valve state and one for thesecond valve state. Certain valve embodiments, as disclosed below, usedin combination with the valve membranes or pressure points integratedinto the manifold, enables more nuanced control, enabling the creationof four distinctly different fluid flow paths.

Pump tube segments 3301, 3302, 3303, 3304 are bonded into the compactmanifold. A number of ports are provided in the manifold, which connectwith tubes external to the manifold to allow the flow of various fluidsin and out of the manifold. These ports are connected to various tubesin the blood purification system for carrying fluids as follows:

Port A 3315—blood to the dialyzer 430;

Port B 3316—dialyzer output (used dialysate);

Port C 3317—blood from the patient;

Port D 3318—heparin for mixing in the blood;

Port E 3319—reservoir output (fresh dialysate);

Port F 3320—dialyzer input (fresh dialysate);

Port G 3321—dialyzer output (blood);

Port H 3322—patient return (clean blood);

Port J 3323—connects to prime and drain line;

Port K 3324—reservoir infusate input;

Port M 3325—infusate in from infusate reservoir; and

Port N 3326—dialysate flow into sorbent.

In one embodiment, a tube segment, formed as a pathway molded into themanifold structure 3300, connects the fluid flow of heparin, enteringvia Port D 3318, to the fluid flow of blood, entering via Port C 3317.The combined heparin and blood flow through port 3317 a, via pumpsegment 3301, and into port 3317 b of the manifold 3300. A pressuretransducer is in physical communication with a membrane 3305, formed inthe manifold structure 3300, which, in turn, passes the blood andheparin fluid through Port A 3315. Fluid flow out of the manifold 3300at Port A 3315 passes through dialyzer 3330, which is external to themanifold 3300. The dialyzed blood passes back into the manifold 3300through Port G 3321 and into a segment 3307, formed as a pathway moldedinto the manifold structure 3300, that is in physical communication withpressure transducer. Fluid then passes from the segment through Port H3322 and into a patient return line.

Separately, dialysis fluid enters the manifold 3300 from a reservoir viaPort E 3319. Fluid in the reservoir has infusate in it, which firstenters the manifold 3300 via Port M 3325, passes through a segment,formed as a pathway molded into the manifold structure 3300, throughanother port 3325 a, through a segment 3302 in communication with apump, and back into the manifold 400 via port 425 b. The infusate passesthrough a segment, formed as a pathway molded into the manifoldstructure 3300, and out the manifold 3300 at Port K 3324, where itpasses into the reservoir. The dialysis fluid which entered the manifoldvia Port E 3319, passes through a segment, formed as a pathway moldedinto the manifold structure 3300, through another port 3319 a, through asegment 3303 in communication with a pump, and back into the manifold3300 via port 3319 b.

The dialysate fluid passes into a segment, formed as a pathway moldedinto the manifold structure 3300, which is in physical communicationwith a pair of valves 3311. A segment, formed as a pathway molded intothe manifold structure 3300, passes the dialysate fluid to another pairof valves 3313. The segment is in physical communication with pressuretransducers 3308 and optional temperature sensor 3310. The dialysatefluid passes out of the manifold 3300 through Port F 3320, and into aline that passes into the dialyzer 3330.

A line out of the dialyzer 3330 passes fluid back into the manifold 3300through Port B 3316 and into a segment, formed as a pathway molded intothe manifold structure 3300, that is in physical communication with afirst pair of valves 3311, a second pair of valves 3312, and a pressuretransducer 3306. The used dialysate fluid passes out of the manifold3300 through port 3326 b, through segment 3304 in communication with apump, and back into the manifold via port 3326 a. A segment in fluidcommunication with port 3326 a is in physical communication withpressure transducer 3309 and passes fluid through Port N 3326 and to asorbent regeneration system.

The ports are designed for circuit tubing (e.g. 0.268″ by 0.175″ tubing)or for anticoagulant and infusate tubing (e.g. 0.161″ by 0.135″).Preferably, the tubing ports are bonded with a suitable solvent. Itshould be appreciated that the valves shown in FIG. 8, specifically,valves 3311, 3312, and, 3313, can be positioned in a different locationswithin the manifold.

Referring to FIG. 19, valve 8611 (valve 3311 in FIG. 8) can bepositioned in the central vertical portion 8650 of the manifold 8600adjacent to and parallel to valve 8612 (valve 3312 in FIG. 8). Also onthe central vertical portion 8650 of the manifold 8600, which connectsthe top horizontal portion 8630 and bottom horizontal portion 8640together, is valve 8613 (valve 3313 in FIG. 8). Valve 8613 is on thebottom portion of the central vertical portion 8650 and positionedsubstantially below and centered between valves 8611, 8612.

The 2-way valves can operate by having valve actuators, which aremounted on the instrument, compress an elastomeric diaphragm over avolcano seal to prevent dialysate flow through its respective pathway,as described in further detail below. The volcano seal opening isapproximately 0.190″ diameter to match the channel geometry. Thecross-sectional pathway through the interior of the valve is at leastequivalent to 0.190″ diameter when valves are open. When the valve is inthe closed position the valve actuator and elastomeric diaphragm consumemost of the fluid path space around the volcano seal minimizing thepotential for air entrapment. There are raised plastic features on themid-body that minimize dead space within the fluid path as well as helpprevent diaphragm from collapsing around the center fluid path undernegative pressure conditions. The elastomeric diaphragm has an o-ringfeature around its perimeter that fits into a groove on the mid-bodysurface. The o-ring is compressed between the mid-body and back cover toform a fluid tight seal. The design provides for approximately 30%compression on the o-ring. The 2-way valves control the direction ofdialysate flow through the manifold.

The manifold contains structures that allow for fluid pressuremonitoring across diaphragms through the use of sensors in theinstrument. Fluid is allowed to flow from channels on the front coverside of the mid-body through inlet and outlet holes underneath thediaphragm on the back cover side. The cross-sectional pathway throughthe interior of the pressure sensing structure is at least equivalent to0.190″. The interior pathway is designed to minimize air entrapmentwhile providing adequate fluid contact with the diaphragm. Theelastomeric diaphragm has an o-ring feature around its perimeter thatfits into a groove on the mid-body surface. The o-ring is compressedbetween the mid-body and back cover to form a fluid tight seal. Thedesign provides for a 30% compression on the o-ring.

The valves and diaphragms can be made from a variety of differentmaterials and by different processes. The elastomeric components can bemade from silicone, a variety of thermoplastic elastomers, a combinationthereof, or the like. Two shot molding may be used to attach the valvesand diaphragms to the back cover. Two shot molding of valves anddiaphragms would remove the need to individually assemble these partsinto the manifold therefore reducing labor costs and improve quality ofthe manifold assembly.

Pumping components in the manifold design have been defined as PVCheader tubing. These headers combined with rotary peristaltic pumpingsystem of the instrument provide the flow of blood, dialysate, andinfusate. The circuit tubing material for dialysate, infusate, andanticoagulant is preferably kink resistant, such as the tubing referredto as Colorite, Unichem PTN 780, (80A durometer) extruded by Natvar, allTEKNIplex companies. The tubing dimensions for the dialysate linesranges from 0.268″.times.0.189″ to 0.268″.times.0.175

Flow within the manifold can be measured by a thermal flow meter. FIG. 9illustrates a thermal fluid flow measurement device 5601 installed withthe manifold 5602 in the dialysis machine 5610. The manifold 5602 hasfluid flow paths or tubing circuit 5603 embedded within. The dialysismachine 5610 has a front door 5620 which can be opened to install thedisposable manifold 5602. Further, the front door 5620 is equipped withpins 5621 that, when the door 5620 is closed, can make contact withelectrical points on the manifold 5602 to read information or provideelectrical input.

The thermal fluid flow measurement device 5601 can further comprise aseries of contacts 5611, 5612 and 5613. Operationally, as fluid (such asblood, dialysate or other fluids) flows during dialysis through thefluid flow path 5603, it passes the first contact 5611 which is embeddedin the plastic pathway. The contact 5611 makes electrical contact withan electrical source, which can be a pin 5621 on the machine front door5620. The electrical source or pin is controlled by a controller in thedialysis machine 5610. The electrical source provides an electricalstimulus to the contact 5611, which acts to micro heat the contact basedon a sine-wave method.

The micro heating process effectuates a temperature increase of between0.1 and 1.0 degrees Celsius in the fluid being measured. This iseffectuated by means of micro heaters located at the first contact 5611,which produce heat on receiving the electrical stimulus. Micro heatersfor the thermal fluid flow measurement device of the present inventioncan be manufactured using any design suitable for the application. Inone embodiment for example, the micro heater is made up of 10 turns of30 g copper wire wound around a pin located at the first contactposition 5611.

As the contact 5611 gets micro-heated, the resulting thermal energy actsto create a thermal wave, which propagates downstream from the firstcontact 5611. A plurality of contacts, which can be two in number—5612and 5613—are located downstream from the first contact 5611, and areused to measure the time of flight of the thermal wave. The measuredphase of the wave is then compared with the initial wave generated bythe first contact 5611. The phase difference thus determined provides anindication of the flow rate.

FIG. 10 is a block diagram of a system 5800 for detecting a patient'sdisconnection from an extracorporeal blood circuit. System 5800comprises an incoming arterial blood circuit 5802, a dialyzer 5804, adialysate circuit 5806, a patient pulse pressure transducer 5808, apatient cardiac signal generator 5815 for reference, a disconnectmonitor 5820, a controller 5825 and a return venous blood circuit 5810.In various embodiments of the present invention, blood drawn from apatient is passed through the dialyzer 5804 via the arterial bloodcircuit 5802 and cleansed blood from the dialyzer 5804 is returned tothe patient via the venous blood circuit 5810. Contaminated dialysateexpelled from the dialyzer 104 is purified or regenerated within thedialysate circuit 5806 and is pumped back into the dialyzer 5804. Thecleansed blood can be returned to a patient's body via a transdermalneedle or a luer connected catheter. Blood flow rates in the returnvenous blood circuit 5810 are typically in the range of 300-400 ml/min.It should be appreciated that any suitable dialysis circuit can bedeployed.

The pressure transducer 5808 measures the pressure pulse of a patientundergoing the blood processing treatment routine and communicates thepulse pressure substantially continuously to the disconnect monitor5820. In one embodiment the transducer 5808 is an invasive ornon-invasive venous pressure sensor located anywhere in the dialysisblood line (the incoming arterial blood circuit 5802 or the returnvenous blood circuit 5810). In another embodiment, the transducer 5808is an invasive or non-invasive venous pressure sensor locatedspecifically in a dialysis blood line between the dialyzer 5804 and thepatient, that is, in the return venous blood circuit 5810. Anon-invasive air bubble detector and/or pinch valve (not shown) areoptionally located between the transducer 5808 and the luer connectionto the patient. The pressure transducer 5808 can be located in closeproximity to the needle or catheter inserted in the patient's body forproviding vascular access corresponding to the return venous bloodcircuit 5810. The pressure transducer 5808 is located in close proximityto the needle or catheter in order to preserve waveform fidelity. Inother embodiments, the pressure transducer 5808 may be connectedanywhere in the return venous blood circuit 5810. In an embodiment ofthe present invention, the pressure signal produced by the pressuretransducer 5808 is an alternating current (AC) signal which is not anaccurate measure of vascular pressure. Hence, the pressure transducer5808 is not a high accuracy transducer.

The reference signal generator 5815 communicates the patient's cardiacsignal substantially continuously to the disconnect monitor 5820 forreference. The reference cardiac signal can be obtained from aplethysmograph connected to the same body part (such as an arm) to whichthe needle or catheter supplying processed blood to a patient isconnected. In some cases the reference cardiac signal is obtained from afinger pulse sensor/oximeter. In various other embodiments of thepresent invention, the reference cardiac signal may be obtained anelectro-cardiogram (ECG) signal, a real time blood pressure signal,stethoscope, arterial pressure signal from the blood withdrawal line,oximeter pulse signal, alternate site plethysmograph signal,transmissive and/or reflective plethysmograph signals, acoustic cardiacsignals, wrist pulse or from any other cardiac signal source known topersons of ordinary skill in the art.

The disconnect monitor 5820 detects a disruption in the return venousblood circuit 5810 caused by the disconnection of a needle or catheter,from the body of a patient undergoing blood processing treatment. Todetect a disconnection, the monitor 5820 processes the patient pulsepressure transducer and cardiac reference signals. Persons of ordinaryskill in the art would appreciate that such disconnection may be causedby the needle or catheter being pulled out of the patient's body due toany reason such as a sudden movement of the patient. The disconnectmonitor 5808 can be of a type known to those skilled in the art.Controller 5825 is any microprocessor known to persons of ordinary skillin the art. The function of the controller 5825 is to receive processedinputs from the monitor 5820 and accordingly trigger appropriateactions, when required.

Persons of ordinary skill in the art should appreciate that the pressuretransducer and reference signals are communicated to the disconnectmonitor 5820 through transmitters incorporated into the reference signalgenerator and pressure transducer. The transmitter can enable a wired orwireless communication to a corresponding receiver. Similarly, data fromthe disconnect monitor 5820 is communicated to the controller 5825through wired or wireless connection. In one embodiment, such signalcommunication is enabled using an appropriate wired or wireless publicand/or private network such as LAN, WAN, MAN, Bluetooth networks, and/orthe Internet. Also, the disconnect monitor 5820 and controller 5825 canbe located in proximity to each other and to the pressure transducer5808 and the cardiac reference signal generator 5815. In an alternateembodiment, both or either of the disconnect monitor 5820 and thecontroller 5825 are/is located remotely from each other and/or from therest of the components of the system 5800.

FIG. 11 is a flow diagram showing exemplary steps of a method ofascertaining patient's disconnection from an extracorporeal bloodcircuit, in accordance with an embodiment of the present invention. Inoperation, dialysis system software, comprising a plurality ofinstructions and executing on a processor, prompts a patient to firstattach a cardiac signal generator (such as a finger pulse oximeter) toobtain 6005 a reference signal. At this point the patient may or may notbe connected to a dialysis system. Thereafter or concurrent to capturingthe cardiac reference signal, the dialysis system software, comprising aplurality of instructions and executing on a processor, prompts apatient to connect to the system 5800 of FIG. 10 as a result of whichpatient pulse pressure transducer signal is also obtained 6010. Next, across correlation processor attempts to correlate 6015 the reference andtransducer signals. If no correlation can be achieved at start-up, inone embodiment, the patient is prompted to turn off 6020 all or certaincomponents or, in another embodiment, the controller 5825 of the system5800 of FIG. 10 does this automatically to lower noise level. Forexample, shutting off the pumps of the dialysis system can lower thenoise and make it easier to capture and correlate the two signals. Inanother embodiment, a cross-correlation is attempted beforenoise-generating system components, such as pumps, are turned on. Thus,lock down of a correlation is attempted before complete system start-upcan be completed. If no correlation is locked down, an alarm can betriggered, indicating the patient dialysis system may have an anomaly.

If a correlation is obtained, however, then that correlation issubstantially continually monitored 6025. If there is any deviation inthat correlation, an alarm is triggered 6030, indicating a possible leakor, optionally, the system is shut down (completely or partially) and anattempt to re-establish the correlated signal is attempted again. If thenature of the correlation changes or deviates beyond or within apredefined threshold, certain system components, such as pumps, can beshut down and the cross correlation processor attempts to re-establishthe correlation. If the correlation cannot be re-established, then analarm is triggered. In some cases, if the nature of the correlationchanges or deviates beyond or outside the range of a predefinedthreshold, certain system components, such as pumps, can be shut downand an alarm is immediately triggered, before any additional attempt tore-establish the correlation.

This approach to monitoring disconnection provides certain distinctimprovements over the prior art. First, unlike the prior art, thepresent system can be responsive if the needle is just barely pulled outor if it is removed and pulled quite some distance from the insertionsite. Second, the system does not need any extra apparatus placed at theinsertion site, such as a moisture pad. Third, by cross correlating thepatients' own cardiac signal, the false negatives are greatlydiminished. Fourth, the combination of pressure pulse sensing and crosscorrelation renders the system capable of detecting low signal to noiseratio signals. Fifth, continuously monitoring the cross correlationstatus enables the system to detect small signal deviations which couldpotentially indicate a disconnection. Therefore, an apparatus and methodfor detection of disconnection in an extracorporeal blood circuit beingused for any blood processing treatment routine, is provided by thepresent invention.

Central Venous Pressure (CVP) can be measured with a remote sensorinside the hemofiltration machine. Referring to FIG. 12, an exemplaryblood circuit 6400 with the provision of CVP measurement is illustrated.As blood enters into the circuit 6400 from the patient, an anticoagulantis injected into the blood using the syringe 6401, to preventcoagulation. A pressure sensor, PBIP 6410 is provided, which is used forthe measurement of central venous pressure. A blood pump 6420 forces theblood from the patient into the dialyzer 6430. Two other pressuresensors, PBI 6411 and PBO 6412, are provided at the inlet and the outletrespectively of the dialyzer 6430. The pressure sensors PBI 6411 and PBO6412 help keep track of and maintain fluid pressure at vantage points inthe hemodialysis system. A pair of bypass valves B 6413 and A 6414 isalso provided with the dialyzer, which ensures that fluid flow is in thedesired direction in the closed loop dialysis circuit. The user canremove air at the port 6417 if air bubbles have been detected by sensor6418. A blood temperature sensor 6416 is provided prior to the airelimination port 6417. An AIL/PAD sensor 6418 and a pinch valve 6419 areemployed in the circuit to ensure a smooth and unobstructed flow ofclean blood to the patient. A priming set 6421 is pre-attached to thehaemodialysis system that helps prepare the system before it is used fordialysis.

For taking CVP measurement, blood flow in the circuit 6400 is stopped bystopping the blood pump 6420. At this point, the pressure in thecatheter used for accessing blood (not shown) will equilibrate, and thepressure measured at pressure sensor PBIP 6410 in the hemofiltrationmachine will be equal to the pressure at the catheter tip. This measuredpressure (CVP) is then used to regulate the rate of ultrafiltration andthe volume of fluid removed from the patient.

Thus, operationally, the system modifies a conventional dialysis systemsuch that ultrafiltration is conducted at a rate preset by thephysician. Periodically, the blood flow is stopped and the average CVPis measured, using one of the various measurement methods describedabove. In one embodiment, a safety mode is provided, wherein if CVPdrops below a preset limit, hemofiltration is discontinued and an alarmsounded.

In another application, a hypervolemic patient such as a patient withCongestive Heart Failure (CHF) may be given ultrafiltration to removefluids. It is known in the art that while the ultrafiltration processremoves fluid from the blood, the fluid that is intended to be removedis located in the interstitial spaces. Further, the rate of fluid flowfrom the interstitial spaces into the blood is unknown. A physician canpre-set the total amount of fluid he wants removed—typically computedfrom patient weight, and the minimal average CVP allowed. The systemthen removes fluid at the maximum rate that automatically maintains thedesired CVP. That is, the system automatically balances the fluidremoval rate with the fluid flow rate from the interstitial spaces intothe blood.

It should be appreciated that normal CVP levels is between 2 and 6 mmHg.Elevated CVP is indicative of over hydration, while decreased CVPindicates hypovolemia. A patient may begin an ultrafiltration sessionwith a CVP above normal, e.g. 7-8 mmHg, and end the session at a finalCVP target of 3 mmHg through, for example, a 6 hour treatment session.However, if midway through the treatment session, CVP has fallen morethan 50% of the desired drop, while the fluid removed has only reached50% of the final target for removal, the system can be reprogrammed toreduce the goal for fluid removal or reduce the rate of fluid removal.Other actions can be taken based on more complicated algorithms. The netresult is that hypovolemia is avoided by monitoring the rate and actualvalue of CVP. It should be appreciated that this approach may also beuseful in controlling fluid removal rates not only duringhemofiltration, but for all types of renal replacement therapies.

FIG. 13 shows an exploded view of the extracorporeal blood processingsystem 6900 configured to operate in hemodialysis mode.

Blood circuit 6920 comprises a peristaltic blood pump 6921 that draws apatient's arterial impure blood along the tube 6901 and pumps the bloodthrough dialyzer 6905. A syringe device 6907 injects an anticoagulant,such as heparin, into the drawn impure blood stream. Pressure sensor6908 is placed at the inlet of the blood pump 6921 while pressuresensors 6909 and 6911 are placed upstream and downstream of the dialyzer6905 to monitor pressure at these vantage points.

As purified blood flows downstream from the dialyzer 6905 and back tothe patient, a blood temperature sensor 6912 is provided in the line tokeep track of temperature of the purified blood. An air eliminator 6913is also provided to remove accumulated gas bubbles in the clean bloodfrom the dialyzer. A pair of air (bubble) sensors (or optionally asingle sensor) 6914 and a pinch valve 6916 are employed in the circuitto prevent accumulated gas from being returned to the patient.

The dialysate circuit 6925 comprises two dual-channel pulsatiledialysate pumps 6926, 6927. Dialysate pumps 6926, 6927 draw spentdialysate solution from the dialyzer 6905 and the regenerated dialysatesolution from reservoir 6934 respectively. At the point where useddialysate fluid from the dialyzer 6905 enters the dialysate circuit6925, a blood leak sensor 6928 is provided to sense and prevent anyleakage of blood into the dialysate circuit. Spent dialysate from theoutlet of the dialyzer 6905 then passes through the bypass valve 6929 toreach two-way valve 6930. A pressure sensor 6931 is placed between thevalves 6929 and 6930. An ultrafiltrate pump 6932 is provided in thedialysate circuit, which is operated periodically to draw ultrafiltratewaste from the spent dialysate and store it in an ultrafiltrate bag6933, which is emptied periodically.

As mentioned previously, spent dialysate can be regenerated usingsorbent cartridges. The dialysate regenerated by means of sorbentcartridge 6915 is collected in a reservoir 6934. The reservoir 6934includes conductivity and ammonia sensors 6961 and 6962 respectively.From the reservoir 6934, regenerated dialysate passes through flowrestrictor 6935 and pressure sensor 6936 to reach a two-way valve 6937.Depending upon patient requirement, desired quantities of infusatesolution from the reservoir 6950 and/or concentrate solution from thereservoir 6951 may be added to the dialysis fluid. Infusate andconcentrate are sterile solutions containing minerals and/or glucosethat help maintain minerals like potassium and calcium in the dialysatefluid at levels prescribed by the physician. A bypass valve 6941 and aperistaltic pump 6942 are provided to select the desired amount ofinfusate and/or concentrate solution and to ensure proper flow of thesolution into the cleansed dialysate emanating from the reservoir 6934.

The dialysate circuit comprises two two-way valves 6930 and 6937. Thevalve 6930 directs one stream of spent dialysate to a first channel ofdialysate pump 6926 and another stream of spent dialysate to a firstchannel of dialysate pump 6927. Similarly, valve 6937 directs one streamof regenerated dialysate to a second channel of dialysate pump 6926 andanother stream of regenerated dialysate to a second channel of dialysatepump 6927.

Streams of spent dialysate from pumps 6926 and 6927 are collected bytwo-way valve 6938 while streams of regenerated dialysate from pumps6926 and 6927 are collected by two-way valve 6939. The valve 6938combines the two streams of spent dialysate into a single stream that ispumped via pressure sensor 6940 and through sorbent cartridges 6915where the spent dialysate is cleansed and filtered, collected in thereservoir 6934. The valve 6939 combines the two streams of regenerateddialysate into a single stream, which flows to the two-way valve 6945through a bypass valve 6947. A pressure sensor 6943 and a dialysatetemperature sensor 6944 are provided on the dialysate flow stream to thetwo-way valve 6945.

By reversing the state of two way valves 6930, 6937, 6938 and 6939 thetwo pumps 6926 and 6927 are reversed in their action of one withdrawingdialysis fluid from the dialyzer 6905 and the other supplying dialysisfluid to the dialyzer 6905. Such reversal, when done periodically overshort periods of time relative to the dialysis session, insures thatover the longer period of the entire dialysis session the dialysatefluid volume pumped into the dialyzer equals the amount of fluid pumpedout and the only total fluid volume lost by dialysis circuit 6925 isthat removed by ultrafiltrate pump 6932, as discussed above.

In hemodialysis mode, two-way valve 6945 allows the regenerateddialysate to enter dialyzer 6905 to enable normal hemodialysis of thepatient's blood. One side of valve 6945 is closed leading to thepatient's blood return line. Another two-way valve 6946 acts as abackup, keeping dialysate form the patient's blood line with both portsof valve 6946 closed even if valve 6945 leaks or fails.

FIG. 14 shows an alternative embodiment of the fluidic circuits wherethe backup two-way valve 6946 is not used. The blood circuit comprisesperistaltic blood pump that draws a patient's arterial impure bloodalong tube 7001 and pumps the blood through dialyzer 7005. A syringe orpump 7007 injects an anticoagulant, such as heparin, into the drawnimpure blood stream. Pressure sensor 7008 is placed at the inlet of theblood pump while pressure sensors 7009 and 7011 are placed upstream anddownstream of a manifold segment. Purified blood from the dialyzer 7005is pumped through tube 7002 past a blood temperature sensor 7012, aireliminator 7013 and air (bubble) sensor 7014 and back to a vein of thepatient. A pinch valve 7016 is also placed before circuit connection ofthe patient to completely stop blood flow if air is sensed by the air(bubble) sensor 7014 in the line upstream of the pinch valve 7016thereby preventing the air from reaching the patient.

The dialysate circuit comprises two dialysate pump segments 7026, 7027in pressure communication with pumps. Dialysate pump segments 7026, 7027draw spent dialysate solution from the dialyzer 7005 and the regenerateddialysate solution from reservoir 7034 respectively. Spent dialysatefrom the outlet of the dialyzer 7005 is drawn through blood leak sensor7028 to reach bypass valve 7029. Flow sensor 7030 is one of two flowsensors (the other being flow sensor 7046) which determine the volume ofdialysate flowing through the circuit. Valve 7030 is similar inconstruction to a two-way valve and is used to bypass dialysate pump7026. Valve 7030 is normally closed in the direction of the bypass. Inthe event the dialysate pump 7026 is stopped, valve 7030 is opened todirect flow around pump 7026. Pressure sensor 7031 is placed between theflow sensor 7030 and the valve 7030. During normal flow, the spentdialysate is pumped via pressure sensor 7040 and through sorbentcartridges 7015 where the spent dialysate is cleansed and filtered. Thecleansed/filtered dialysate then enters reservoir 7034. An ultrafiltratepump 7032 is operated periodically to draw ultrafiltrate waste from thespent dialysate and store in an ultrafiltrate bag (not shown) that isemptied periodically.

Regenerated dialysate from the reservoir 7034 passes through flowrestrictor 7035, dialysate temperature sensor 7044, flow sensor 7046 andpressure sensor 7036 to reach two-way valve 7045 through bypass valve7041. When the respective flow paths of bypass valves 7029, 7045 and7041 are activated they direct regenerated dialysate to bypass thedialyzer 7005. Infusate and concentrate streams from infusate andconcentrate reservoirs 7050, 7051 are directed by infusate andconcentrate pump segments 7042, 7043 into the cleansed dialysateemanating from the reservoir 7034 and the spent dialysate downstream offlow sensor 7030, respectively.

The two-way valve 7045 determines what mode the system is operating in.Thus, in one mode of operation the two-way valve 7045 allows theregenerated dialysate to enter dialyzer to enable normal hemodialysis ofthe patient's blood. In another mode of operation, the two-way valve7045 is actuated to direct fluid flow of ultra pure infusate gradedialysis fluid into the venous blood line and directly to patient.Accordingly, the versatile valves enable the mode of operation to switchbetween hemofiltration and hemodialysis. For example, in hemofiltration,infusible grade fluid is routed through the three valves directly intothe blood stream where valve 6946 connects to the post dialyzer. In thismode valve 6945 prevents the dialysate fluid from entering the lowerport of the dialyzer. In hemodialysis, shown in FIG. 13, valve 6946 isclosed and valves 6947 and 6945 route dialysate fluid to the dialyzer.It should be noted that the embodiment of FIG. 13 uses pump swapping anda plurality of valves to control fluid volume while the embodiment ofFIG. 14 uses flow sensors 7030 and 7046 to control fluid volume.

As discussed above, valves are preferably implemented in a manifoldusing elastic membranes at flow control points which are selectivelyoccluded, as required, by protrusions, pins, or other members extendingfrom the manifold machine. In some cases, fluid occlusion is enabledusing a safe, low-energy magnetic valve.

The valve system comprises a magnetic displacement system that islightweight and consumes minimum power, making it ideal even when theportable kidney dialysis system uses a disposable manifold for fluidiccircuits. The system can be used in conjunction with an orifice in anystructure. In particular, an orifice is any hole, opening, void, orpartition in any type of material. This includes pathways in tubing,manifolds, disposable manifolds, channels, and other pathways. One ofordinary skill in the art would appreciate that the presently disclosedvalve system would be implemented with a disposable manifold bypositioning the displacement member and magnets, as further discussedbelow, external to the manifold at the desired valve location. Theactuator is also separate and distinct from the disposable manifold andgenerally part of the non-disposable portion of the kidney dialysissystem.

Functionally, the valve has two stable states: open and closed. Itoperates by using magnetic forces to move a displacement member againsta diaphragm and thereby create sufficient force to press the diaphragmagainst a valve seat and cause the diaphragm to close the orifice.Closing of the orifice shuts off fluid flow. The reverse process, namelythe use of magnetic forces to move a displacement member away from thediaphragm and thereby release the diaphragm from compression against thevalve seat, opens the orifice and permits fluid to flow.

FIG. 15 is a flowchart showing another process 8000 for initiating adialysis treatment. The controller unit 8001 can comprise at least oneprocessor and memory storing a plurality of programmatic instructions.When executed by the processor, the programmatic instructions generate aplurality of graphical user interfaces, displayed on the controllerdisplay, which directs a user through a series of actions designed toreliably acquire and measure the additives required for use in adialysis treatment. A first graphical user interface is generatedthrough which a user can prompt the system to initiative the additiveaccounting process 8001. The initial prompt can be through a specificicon for initiating the process or can occur as part of a larger systemsetup.

A second graphical user interface is then generated 8003 which displaysin text or graphical form the additives required, preferably including avisual image of the actual additive package to permit a user to visuallycompare the additive required with the product the user has on-hand. Theuser is then prompted 8005 to indicate whether he wishes to verify theadditive using a bar code scan or by weight. If the user indicates hewishes to use the bar code scan, through, for example, pressing an icon,a third graphical user interface is generated 8007 prompting the user topass the first additive past the bar code scanner. The user then passesan additive, preferably in any order, past the bar code scanner,registering a read. It should be appreciated that the bar code scannercan comprise a light, such as a red light, which changes color, such asto green, upon a successful reading.

If the system successfully reads the bar code it processes 8009 the codeby checking the code against a table stored in memory. The table storedin memory associates bar codes with specific additives. Once a specificadditive is identified, the second graphical user interface, asdescribed above, is updated 8011 with a check mark or highlight toindicate which additive has been successfully scanned and the user isinstructed to set the additive aside. This process is repeated 8019 forall additives. In one embodiment, once all additives are highlighted orchecked, the system automatically proceeds to the next step in thedialysis set up or initialization process. In another embodiment, onceall additives are highlighted or checked, the system presents agraphical user interface informing the user that all additives have beenregistered, after which a user causes the system to manually proceed tothe next step in the dialysis set up or initialization process. Itshould be appreciated that, while the term bar code is used, anyelectronic tagging or labeling system can be used, including, forexample, radio frequency identification (RFID) tags.

If, for any scanning step 609, the bar code is not recognized, theadditives do not have bar codes, or the user prefers to verify additivesusing weighing, as opposed to scanning, a graphical user interface ispresented to the user prompting 8013 the user to place a first additiveon the scale. The scale measures the additive package weight 8015 andcompares the measured weight to a table of weight values associated withspecific additives in order to recognize the additive. Once recognized,the second graphical user interface, as described above, is updated 8017with a check mark or highlight to indicate which additive has beensuccessfully scanned and the user is instructed to set the additiveaside. This process is repeated 8019 for all additives. In oneembodiment, once all additives are highlighted or checked, the systemautomatically proceeds to the next step in the dialysis set up orinitialization process. In another embodiment, once all additives arehighlighted or checked, the system presents a graphical user interfaceinforming the user that all additives have been registered, after whicha user causes the system to manually proceed to the next step in thedialysis set up or initialization process. It should be appreciatedthat, while the term bar code is used, any electronic tagging orlabeling system can be used.

If the additive is not recognized, the user is informed that theadditive is not part of the treatment process and is prompted to weigh aproper additive. In another embodiment, if the user fails to scan orweigh a recognized additive, the user is not permitted to continue theinitialization or set up process.

One of ordinary skill in the art would appreciate that although theaforementioned verification procedure has been described forprescription additives, the same procedure may also be extended to thedisposable components used with the dialysis system, such as sorbentcartridges and other disposables.

It should further be appreciated that the process of scanning andweighing the additives can be integrated and automated. As discussedabove, a user can be prompted to initiate the additive weighing processand a display of items needed for treatment may be displayed. A userplaces an additive on a scale which has a bar code reader proximate toor integrated therein. In one embodiment, the user is prompted to placethe additive in a specific position or configuration to ensure the barcode can be properly read. Upon placing the additive on the scale havingan integrated or combined bar code reader, the bar code reader scans theadditive, attempts to recognize the bar code, and, if recognized,processes the item by checking or highlighting the identified additiveon the display. If the bar code reader fails to identify the additive,if the system requires an additional, supplemental check, or if thesystem wishes to obtain or otherwise record weight information, thescale measures the weight and attempts to recognize the additive againststored values. If identified, the system processes the item by checkingor highlighting the identified additive on the display. The scalemeasurement and bar code reader can therefore occur without having tomove the additive from one location or position to another.

It should further be appreciated that the additives can be inserted intoa holding container, chute, cylinder, box, bucket, or staging area thatwill automatically drop, place, or otherwise position each additive intothe appropriate position on a scale/bar code reader. Accordingly, theuser can place all additives into a single container, activate thesystem, and have each additive sequentially positioned on the scale andidentified automatically. A user may be prompted to remove each additiveafter each additive is recognized or maybe prompted to allow alladditives to be processed first.

It should further be appreciated that the additive can be added to thesystem automatically after identification, manually afteridentification, and either before or after the hemofilter and/or sorbentcartridge is installed. In one embodiment, the top or bottom unit of theportable dialysis system also preferably has electronic interfaces, suchas Ethernet connections or USB ports, to enable a direct connection to anetwork, thereby facilitating remote prescription verification,compliance vigilance, and other remote servicing operations. The USBports also permit direct connection to accessory products such as bloodpressure monitors or hematocrit/saturation monitors. The interfaces areelectronically isolated, thereby ensuring patient safety regardless ofthe quality of the interfacing device.

In another embodiment, the dialysis machine comprises an interface, inthe form of a graphical user interface with touch screen buttons,physical keypad, or mouse, which can be manipulated to cause a dialysismachine loaded with a manifold to start operation in either a treatmentmode or priming mode. When instructed to operate in treatment mode, thecontroller generates a signal (in response to that treatment modecommand) to cause the manifold valve to switch from an open, primingstate to a closed, treatment state. When instructed to operate inpriming mode, the controller generates a signal (in response to thatpriming mode command) to cause the manifold valve to switch from aclosed, treatment state to an open, priming state. One of ordinary skillin the art would appreciate that all of the aforementioned control anduser command functions are effectuated by incorporating one or moreprocessors, executing programming embodying the aforementionedinstructions, which are stored in local memory.

When properly actuated, the system can operate in at least a primingmode and a treatment mode, which can comprise other modes of operation(such as hemodialysis, hemofiltration, or, simply, a non-priming mode).

Embodiments of the dialysis systems disclosed herein can be designed touse a plurality of disposable components. Disposables for use in thesystem can be shipped in packaging preassembled on a tray. The tray canbe placed on top of the controller unit workspace, thereby permittingeasy access to, and management of, the required disposables, which is ofparticular importance inside a vehicle. The controller unit can bewaterproof rated, so that, in case of a liquid spill, liquid will notseep into and damage the controller unit.

In an exemplary embodiment, shown in FIG. 16, a disposable kit 8200 isprovided that contains a manifold 8202, dialyzer 8201, and tubing 8203which are all preattached. Referring to FIG. 16, the disposable kit 8200comprises a dialyzer 8201, manifold 8202, tubing 8203, valves 8204 (aspart of the manifold), reservoir bag 8205, which are all preattached andconfigured for direct installation into the dialysis machine by a user.

The disposable components, particularly the fully disposable blood anddialysate circuits, can be prepackaged in a kit (which includesdialyzer, manifold, tubing, reservoir bag, ammonia sensor, and othercomponents) and then installed by a user by opening the front door ofthe unit, installing the dialyzer and installing the manifold in amanner that ensures alignment against non-disposable components such aspressure, sensors, and other components. A plurality of pump shoesintegrated into the internal surface of the front door makes loading ofdisposable components easy. The manifold only needs to be inserted andno pump tubing needs to be threaded between the rollers and shoes. Thispackaged, simple approach enables easy and quick disposables loading,and cleaning of the system. It also ensures that the flow circuitry isproperly configured and ready for use. In operation, a separate unit,receptacle, trunk, glove box, or cabinet can be provided to house thereservoir.

With respect to an exemplary treatment mode and referring to FIG. 17,the dialysis system 8400 operating in dialysis mode comprises a dialyzer8402, sorbent regeneration system (e.g. cartridge) 8412, manifold 8410,infusate source 8416 entering into the manifold 8410 through a port, andreservoir 8415 from which fresh dialysate is input back into themanifold 8410 via a port. In operation, blood enters the blood line8401, into the manifold 8410 through a port, through a two-way valve8421 which is in a first position, and into the dialyzer 8402. Thepurified blood exits the dialyzer 8402 through outlet 8403, through atwo-way valve 8422 which is in a first position, and into the manifold8410 through a port. The blood passes through the manifold, passingthrough a plurality of valves, as described above in relation tomanifold 8410, and out of a port and into a blood line 8423 entering thepatient.

Concurrently, infusate passing from a source 8416 passes into themanifold 8410 through a port, through the manifold 8410, out throughanother port, and into reservoir 8415, from which dialysate is deliveredvia a dialysate in-line 8424 and into dialyzer 8402. After passingthrough the dialyzer 8402, the dialysate passes through an out-line 8425and back into the manifold 8410 through a port where it is routed to thesorbent-based dialysate regeneration system 8412 via a port. Regenerateddialysate passes back through the manifold 8410 via a port and isrecirculated through the dialyzer 8402 with new dialysate, if and whenrequired. To manage dialysate fluid flow, a reservoir 8415 is used tostore regenerated dialysate, if and when needed. In some embodiments,the reservoir can hold 5 liters of dialysate and has the capacity tohold up to 10 liters of dialysate and effluent from the patient.

With respect to an exemplary priming mode and referring to FIG. 18, adialysis system 8500 operating in priming mode comprises a dialyzer8502, sorbent regeneration system (e.g. cartridge) 8512, manifold 8510,infusate source 8516, and reservoir 8515. In operation, the bloodlinefrom the patient (e.g. 8401 in FIG. 17) into the manifold 8510 is notconnected and therefore, no blood is flowing, or capable of flowing,into the manifold 8510. Rather, dialysate passing from a source 8515passes into the manifold 8510 through a plurality of ports and through adialysate in-line 8524, which is connected to the two-way valve port8522.

A single two-way valve can be incorporated into the physical body of themanifold and manipulated to switch between a treatment mode of operationand a priming mode of operation. In this embodiment, a manifoldcomprises a two-way valve which, if activated or switched from a firstpositioned (e.g. closed) to a second position (e.g. open), causes achange to the internal flowpath of liquid within the manifold. As aresult of this flowpath change, the blood and dialysate circuits, which,when the valve is closed, are fluidically isolated from each other, arenow placed in fluid communication with each other. Preferably, noadditional valves or switches need to be manipulated in order to achievethis state change, namely, to cause separate blood and dialysatecircuits to become fluidly connected.

The valve switch may be effectuated by any means known in the art,including by physically manipulating a mechanical control on the surfaceof the manifold or electronically through the operation of a dialysismachine causing a change to the valve state through an interface betweenthe dialysis machine, which has a controller to control the state of thevalve in accordance with a user-selected operational mode, and a valveinterface integrated into the surface of the manifold.

In priming mode, the valve would be opened, thereby causing dialysatefluid flowing through a pump to pass through the manifold, into thedialyzer, out of the dialyzer, back into the manifold, and out ofmanifold. Accordingly, in the priming mode, the valve ensures that thedialysate circulates through the blood circuit, thereby placing theblood and dialysate circuits in fluid communication. Functionally, themanifold is placed in priming mode, by manipulating the state of thetwo-way valve.

After a specified volume of dialysate is pumped into and through theblood circuit, the two-way valve is closed. Pumping of dialysate may ormay not continue. If continued, the fresh dialysate circulates throughthe dialysate circuit only. In the blood circuit, residual dialysateremains. To purge the dialysate from the blood circuit, a patient isconnected to the “From Patient Line” 8401, shown in FIG. 84 andtypically referred to as the arterial access line. The “To Patient Line”8423, typically referred to as the venous return line is either heldover a waste container or connected to a patient.

Placing the system in treatment mode, blood from the patient is drawninto the blood circuit, passing into the manifold, through pumps, out ofthe manifold, through the dialyzer, back into the manifold, and back outof the manifold. The blood thereby causes the residual priming fluid tobe ‘chased’ through the blood circuit, removing any remaining airpockets in the process, and into either a waste container or thepatient, depending on the connected state of the venous return line.After blood has completely filled the blood circuit, the system stopsthe blood pump or the user stops the pump manually. If not alreadyconnected, the venous return line is then connected to the patient andthe treatment continues.

In another embodiment, a filter, such as a 0.22.mu. filter, can be usedto help remove any remaining undesirable substances if thesorbent-canister is inadequate to produce essentially sterile dialysate.As an example, the filter is positioned in-line with the reservoir inputline, proximate to Port E of the manifold, and is used both duringpriming and operation.

By using this priming system, one avoids having to use an additional andseparate set of disposables to just prime the blood side of the circuit.In particular, this approach eliminates the need for a separate salinesource, such as a 1 liter bag of saline, and, accordingly, alsoeliminates the need for connectors and tubing to the separate salinesource, including dual-lumen spikes or single lumen spikes used toconnect blood lines to the saline.

FIG. 19 depicts, among other elements, a disposable conductivity sensor8690 comprising a tubular section with a first end for receiving a firstdisposable tubing segment and a second end for receiving a seconddisposable tubing segment. The tubular section comprises a firstplurality of probes that extend into the interior volume defined by thetubular section and constitute the fluid flowpath. In one embodiment, atleast three separate, elongated probes are employed. In anotherembodiment, at least four separate, elongated probes are employed.

The disposable conductivity sensor 8690 is adapted to attach to acomplementary, mating second plurality of probes that are fixedly and/orpermanently attached to the exterior side of the control unit. The siteof attachment can comprise a portion of the exterior surface of thecontrol unit proximate to, or on the same side as, the dialyzer.Operationally, disposable conductivity sensor 8690 is snapped into atemporary, but attached, relation to the complementary, matingnon-disposable plurality of probes. Therefore, the second plurality ofprobes is received into, and positioned in communication with, the firstplurality of probes. The probes then operate by emitting and detectingsignals within the fluid flow path defined by the first disposabletubing segment, tubular section of the conductivity sensor, and seconddisposable tubing segment, and then transmitting detected signals to amemory and processor within the control unit for use in monitoring andcontrolling the dialysis system.

Referring to FIG. 19, a method and system for safely and efficientlyperforming a saline rinse back is shown. Conventionally, a saline rinseback, which serves to flush the system with saline, is performed bydetaching a tubular segment 8658 that connects the dialysis bloodcircuit to the patient at connection 8651 and attaching the tubularsegment 8658 to a saline source 8602 via connection points 8652 and8653. This conventional approach has disadvantages, however, includingthe breaching of a sterile connection. It should be appreciated that theconnection points can be any form of connection, including luerconnections, snap fits, needle-less inserts, valves, or any other formof fluidic connection.

Another approach to a saline rinse back includes connecting the salinesource 8602 via connection point 8652 to connection point 8653, whilemaintaining the connection to the patient. While it avoids breaching thesterile connection, it exposes a patient to a saline fluid flow.Accordingly, a preferred approach to performing a saline rinse back isto maintain the blood circuit connection between the patient and thedialysis system via tubular segment 8658, which connects to the manifold8600 at port C 8605 and the patient at connection point 8651 andfluidically connects the saline source 8602 to the manifold 8600 at portD 8606. With the patient still fluidically connected to the dialysissystem, saline is permitted to flow, by gravity or applied pressure,into the manifold 8600 via port D 8606, which is adjacent to port C8605. The saline flow serves to flush the manifold 8600 with saline and,in particular, to flow out of the manifold 8600 via port C 8605, throughtubular segment 8658, and into the patient via connection 8651. Becausean air bubble detector is present in region 8654, proximate to port C8605, when the manifold 8600 is installed in the controller unit andtherefore adapted to detect air bubbles in fluid flow exiting port C8605, saline exiting the manifold 8600 and toward the patient will bemonitored for air bubbles, via the air bubble detector in region 8654.If an air bubble is detected, a low level alarm will sound, therebysignaling to a patient that he or she should either disconnect from thesystem or extract the air bubble, using a syringe, from access point8610. Accordingly, this method and system for conducting a saline rinseback maintains a sterile connection while still monitoring and alarmingfor the presence of air bubbles.

The entire contents of all references cited in this disclosure areincorporated herein in their entireties, by reference. Further, when anamount, concentration, or other value or parameter is given as either arange, preferred range, or a list of upper preferable values and lowerpreferable values, this is to be understood as specifically disclosingall ranges formed from any pair of any upper range limit or preferredvalue and any lower range limit or preferred value, regardless ofwhether ranges are separately disclosed. Where a range of numericalvalues is recited herein, unless otherwise stated, the range is intendedto include the endpoints thereof, and all integers and fractions withinthe range. It is not intended that the scope of the invention be limitedto the specific values recited when defining a range.

Other embodiments of the present invention will be apparent to thoseskilled in the art from consideration of the present specification andpractice of the present invention disclosed herein. It is intended thatthe present specification and examples be considered as exemplary onlywith a true scope and spirit of the invention being indicated by thefollowing claims and equivalents thereof.

What is claimed is:
 1. A vehicle comprising: a vehicle navigation systemcomprising a first input device configured to accept a destinationinput, the vehicle navigation system configured to calculate a travelduration for the vehicle to reach the destination; a dialysis machinecomprising a control unit and a second input device configured to accepta prescription therapy input, the control unit configured to accept thetravel duration from the vehicle navigation system and to calculate arate of treatment to complete the inputted prescription therapy withinthe travel duration, the dialysis machine configured to perform adialysis treatment on a patient while the vehicle is operating; a shareddisplay screen; and an interface providing an electrical communicationbetween the dialysis machine and the vehicle navigation system, whereinthe shared display screen is configured to display navigationinformation and dialysis therapy information.
 2. The vehicle of claim 1,wherein the dialysis machine further comprises a transmitter and areceiver, the transmitter is configured to transmit wireless signalspertaining to the dialysis machine, and the receiver is configured toreceive wireless signals pertaining to the dialysis machine.
 3. Thevehicle of claim 2, further comprising a dialysis machine alarm systemconfigured to determine the nearest hospital, dialysis clinic, urgentcare center, or other emergency care center, using the wireless signals,and the vehicle navigation system is configured to navigate the vehicleto the nearest hospital, dialysis clinic, urgent care center, or otheremergency care center, for corrective measures.
 4. The vehicle of claim1, further comprising a vehicle electrical system, a car battery, analternator for charging the car battery during operation of the vehicle,and a backup battery dedicated to the dialysis machine, wherein thebackup battery is in electrical communication with the alternator andthe vehicle electrical system is configured to charge the backup batteryduring operation of the vehicle.
 5. The vehicle of claim 4, wherein thevehicle electrical system comprises an ignition switch and an ignitionswitch bypass circuit configured to provide battery power from thebackup battery to the dialysis machine in the event that the ignitionswitch is turned off during a prescription therapy.
 6. The vehicle ofclaim 1, wherein the dialysis machine comprises a blood flow circuit,the blood flow circuit comprising: a blood pump; a dialyzer; an arterialtube configured to be connectable to a patient blood flow system; avenous tube configured to be connectable to a patient blood flow system;and an emergency state alarm system operably configured to indicate anemergency condition, and wherein the emergency state alarm system isconfigured such that, upon activation, the vehicle navigation systemnavigates the vehicle to a hospital, a dialysis clinic, an urgent carecenter, or another emergency care center, for corrective measures. 7.The vehicle of claim 1, wherein the dialysis machine comprises at leastone blood pump and an alarm system, the alarm system being configured tostop operation of the at least one blood pump in response to receiving alow level alarm signal, and the vehicle navigation system is configuredto navigate the vehicle to the nearest emergency care center in responseto receiving an emergency state alarm signal from the alarm system. 8.The vehicle of claim 1, further comprising a vehicle interior, whereinthe dialysis machine further comprises a receiver fixedly attached tothe vehicle interior and configured to receive disposable dialysisequipment.
 9. The vehicle of claim 8, wherein the dialysis machinefurther comprises a door having an interior face and a housing builtinto the interior of the vehicle and including a panel, the housing andthe panel together define a recessed region configured to receive theinterior face of the door, and the receiver is fixedly attached to thepanel.
 10. The vehicle of claim 8, wherein the vehicle comprises a frontseat and a back seat behind the front seat, and the control unit ismounted in the front seat with the second input device facing the backseat.
 11. The vehicle of claim 8, wherein the vehicle comprises a dashboard and the control unit is mounted in or on the dash board.
 12. Thevehicle of claim 8, further comprising a catch basin, wherein thevehicle interior comprises a floor, the dialysis machine comprises aplurality of connectors, the catch basin is secured to the floor, andthe catch basin is positioned with respect to the dialysis machine tocatch liquid that drips from the connectors in the event that liquiddrips from one or more of the plurality of connectors.
 13. The vehicleof claim 1, further comprising: an energy source; and an energy sourcelevel sensor, wherein the control unit is configured to receive a signalsent from the energy source level sensor and to calculate the amount ofenergy needed to operate the vehicle and the dialysis machine togetherfor a time needed to complete the dialysis treatment.
 14. The vehicle ofclaim 13, further comprising an engine, wherein the energy sourcecomprises a fuel source for the engine, the energy source sensorcomprises a fuel sensor configured to sense the amount of fuel availablefor the engine, the interface between the dialysis machine and thevehicle navigation system comprises an electrical communication betweenthe fuel sensor and the control unit, the prescription therapy includesa value for the amount of time required to carry out the prescriptiontherapy, the fuel sensor is configured to send a signal to the controlunit indicating the amount of fuel available to power the engine, andthe control unit is configured to notify the user if there isinsufficient fuel to power the engine for the amount of time that wouldbe required to carry out the prescription therapy.
 15. The vehicle ofclaim 13, further comprising a battery-operated motive engine motor,wherein the energy source comprises a battery configured to supplybattery power to the engine motor, the energy source level sensorcomprises a battery sensor configured to sense the amount of batterypower available for the engine motor, the interface between the dialysismachine and the vehicle navigation system comprises an electricalcommunication between the battery sensor and the control unit, theprescription therapy includes a value for the amount of time required tocarry out the prescription therapy, the battery sensor is configured tosend a signal to the control unit indicating the amount of battery poweravailable to power the engine motor, and the control unit is configuredto notify the user if there is insufficient battery power to power theengine motor for the amount of time that would be required to carry outthe prescription therapy.
 16. The vehicle of claim 1, wherein thevehicle comprises an automobile.
 17. The vehicle of claim 1, wherein thevehicle comprises a seat having a vehicle seat back, and the secondinput device is incorporated into the vehicle seat back.
 18. The vehicleof claim 17, further comprising a patient seat directly behind andfacing the vehicle seat back.
 19. The vehicle of claim 1, wherein theshared display screen is configured to display the navigationinformation and the dialysis therapy information simultaneously.
 20. Avehicle comprising: a vehicle navigation system comprising a first inputdevice configured to accept a destination input, the vehicle navigationsystem configured to calculate a travel duration for the vehicle toreach the destination; a dialysis machine comprising a control unit anda second input device configured to accept a prescription therapy input,the control unit configured to accept the travel duration from thevehicle navigation system and to calculate a rate of treatment tocomplete the inputted prescription therapy within the travel duration,the dialysis machine configured to perform a dialysis treatment on apatient while the vehicle is operating; a vehicle electrical system; andan interface providing an electrical communication between the dialysismachine and the vehicle navigation system, wherein the dialysis machineis hardwired into the vehicle electrical system.